System for heat exchange with a circulating fluid

ABSTRACT

The present invention provides systems, methods, and articles for stress reduction and sleep promotion. A stress reduction and sleep promotion system includes at least one remote device, at least one body sensor, and at least one remote server. The sleep promotion devices includes a control unit able to thermoelectrically heat or cool a fluid circulating through a mattress pad. In one embodiment, the control unit includes Peltier chips connected to two heat sinks via heat pipes, with both heat sinks attached to a fan for dissipating heat. In another embodiment, the control unit further includes EMF shielding for reducing EMF interference with a user&#39;s sleep.

CROSS REFERENCE TO RELATED APPLICATIONS

This application relates to and claims priority from the followingapplications. This application is a continuation-in-part of U.S. patentapplication Ser. No. 16/715,652, filed Dec. 16, 2019, which claims thebenefit of U.S. Provisional Patent Application No. 62/780,637, filedDec. 17, 2018. U.S. patent application Ser. No. 16/715,652 is also acontinuation-in-part of U.S. patent application Ser. No. 15/848,816,filed Dec. 20, 2017. U.S. patent application Ser. No. 15/848,816 is acontinuation-in-part of U.S. application Ser. No. 15/705,829, filed Sep.15, 2017, which is a continuation-in-part of U.S. application Ser. No.14/777,050, filed Sep. 15, 2015, which is the National Stage ofInternational Application No. PCT/US2014/030202, filed Mar. 17, 2014,which claims the benefit of U.S. Provisional Application No. 61/800,768,filed Mar. 15, 2013. U.S. application Ser. No. 15/705,829 also claimsthe benefit of U.S. Provisional Application No. 62/398,257, filed Sep.22, 2016. Each of the above applications is incorporated herein byreference in its entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This invention relates broadly and generally to articles, methods, andsystems for exchanging heat with a circulating fluid, and specificallyto articles, methods, and system for exchanging heat with a fluid usedto heat or cool a mattress pad.

2. Description of the Prior Art

It is generally known in the prior art to provide atemperature-conditioned surface. It is desirable to control thetemperature of a bed or other piece of furniture that supports a person,such as when sleeping. Such control has therapeutic value in treatingsymptoms of menopause or conditions of hypothermia or hyperthermia,particularly when those conditions manifest themselves over a longperiod of time. Therapeutic value may also be seen for individuals whohave circulatory disorders, sleep disorders, and other conditions thatmay be improved by increasing the comfort felt during sleep. Suchcontrol can be desirable even outside the therapeutic value of coolingor heating a surface (e.g., mattress), simply to match the personalcomfort preferences of healthy individuals, to promote higher qualitysleep, or to provide localized control when a more general control(e.g., heating or air conditioning of a sleeping space) is unavailableor when adjustments to the general control would cause others discomfortor would be inefficient from an energy consumption perspective.

Various methods of temperature control are known, including such classicsystems as electric blankets or heating pads, as well as more recentdevelopments that involve the circulation of a heated or cooled fluidthrough a mattress, such as directing air through the chambers of an airmattress or directing air or a fluid through a tube that is embeddedwithin a mattress or a mattress pad. The more advanced of these systemsutilize a heat source or sink (i.e., cooling source) to heat or cool areservoir of fluid to a selected target temperature and pump the heatedor cooled fluid through the available conduit, relying on principles ofheat exchange to control the surface temperature.

Furthermore, it is also critical to limit exposure to electromagneticfield (EMF) radiation to sleepers. Studies have shown that longer termexposure to even low intensity EMF radiation, which includes radiationgiven off by common household electronic devices, such as phones, TVs,computers, refrigerators, etc., can decrease the quality of a user'ssleep. While the precise mechanism by which EMF radiation interruptssleep or decreases sleep quality is unknown, some have posited that itmay involve interference with brain signals.

Various methods and systems for heating or cooling circulating fluidsare known. These systems commonly utilize heat sinks having a pluralityof fins to dissipate excess heat from the fluid.

Prior art patent documents include the following:

U.S. Pat. No. 7,908,687 for device for temperature conditioning an airsupply by inventors Ward et al., filed Feb. 15, 2007 and issued Mar. 22,2011, is directed to a heating and cooling device for temperatureconditioning an air supply for an air conditioned appliance, saidheating/cooling device comprising: a first air passage for channeling afirst air flow; a second air passage for channeling a second air flow;an inlet fan for drawing air into said first, air passage; an exhaustfan for drawing air through said second air passage; one or a pluralityof heat exchangers for exchanging heat between air in said first airpassage and air in said second exhaust air passage; wherein said firstair passage comprises a tubular channel having an inlet at a first endand only one outlet, said outlet being at a second end of said passage,and said inlet fan is positioned at said inlet, such that said first airflow is channeled through said inlet fan, along the whole of said airpassage, encountering all of said one or plurality of heat exchangers,and out of said outlet.

U.S. Pat. No. 7,546,653 for air mattress by inventor Ye, filed Aug. 23,2005 and issued Jun. 16, 2009, is directed to an air mattress includes amattress envelope having a compartment and comprising a thermalfunctional layer and an outer layer overlapped thereon and an aircushion including a plurality of individual air chambers evenly disposedin the compartment of the mattress envelope and an air supplying tubecommunicatively interconnecting the air chamber with each other. Athermal control arrangement includes a liquid supplying tube spirallyextending at the thermal functional layer of the mattress envelope forguiding a flow of thermal liquid and a thermal energy generator arrangedto regulate a temperature of the thermal liquid such that when thethermal liquid passes through the liquid supplying tube, the thermalliquid thermo-communicating with the thermal functional layer of themattress envelope towards the outer layer so as to regulate atemperature of the mattress envelope.

U.S. Publication No. 20070234741 for heat radiator having athermo-electric cooler and multiple heat radiation modules and themethod of the same by inventors Lee et al., filed Apr. 11, 2006 andpublished Oct. 11, 2007, is directed to a heat radiator has athermo-electric cooler and multiple heat radiation modules and themethod of the same is capable of applying forced heat conduction on ahot spot on a computer circuit through a plurality of conduction paths.The heat radiator comprises a first heat radiation module with a heatsink simultaneously attached to the hot spot and the thermo-electriccooler and a second radiation module with a heat sink attached on thethermo-electric cooler only, whereby the heat generated in a heatsource, such as a central processing unit (CPU) and an acceleratedgraphic chip, and delivered from the heat absorption terminal to theheat release terminal of the cooler can be dissipated efficiently. Thefirst heat radiation module and the second radiation module furtherrespectively include a first and a second radiating fin sets.

U.S. Publication No. 20190203983 for cooling apparatus usingthermoelectric modules by inventors Jeon et al., filed Mar. 30, 2018 andpublished Jul. 4, 2019, is directed to a cooling apparatus usingthermoelectric modules. The cooling apparatus includes a coolingcontainer, a first thermoelectric module contacting the coolingcontainer at a first position, and a first heat dissipating modulecontacting the first thermoelectric module. The first heat dissipatingmodule includes a loop heat pipe including a first evaporation unitcontacting the first thermoelectric module and provided with a wickstructure located therein, a first condensation unit located at theoutside of the cooling container, a first vapor pipe line configured tointerconnect one side of the first evaporation unit and one side of thefirst condensation unit such that gas is placed therein, and a firstliquid pipe line configured to interconnect the other side of the firstevaporation unit and the other side of the first condensation unit suchthat a working fluid is placed therein.

U.S. Publication No. 20170138663 for beverage cooling system by inventorWells, filed May 13, 2016 and published May 18, 2017, is directed tovarious systems, processes, and techniques may be used for coolingbeverages. In one general implementation, a beverage cooling system mayinclude a pump, a cooling subsystem, and a control subsystem. The pumpmay circulate a coolant that is used to keep a beverage in a pythoncool, the cooling subsystem may extract heat from the coolant to keep itcool, and the control subsystem may monitor the coolant temperature andcontrol the cooling subsystem. The cooling subsystem may include acooling block, a thermoelectric cooler, a heat distributor, a heat pipeassembly, a fin assembly, and a fan. The cooling block may be adapted toreceive the coolant and receive heat therefrom. The thermoelectriccooler may be thermally coupled to one side of the cooling block andadapted to extract heat from the cooling block.

U.S. Pat. No. 6,463,743 for modular thermoelectric unit and coolingsystem using same by inventor Laliberte, filed Mar. 12, 2002 and issuedOct. 15, 2002, is directed to a modular thermoelectric cooling/heatingunit is installed through an opening in a wall separating first andsecond temperature zones. This modular thermoelectric cooling/heatingunit comprises a thermoelectric device including a cold surface, a hotsurface, and a cooling/heating member between an electrical power supplyand the cold and hot surfaces. A heat conducting block has a proximalend for thermally contacting with a first one of the cold and hotsurfaces, and a distal end. A first heatsink thermally contacts with asecond one of the cold and hot surfaces, a second heatsink thermallycontacts with the distal end of the heat conducting block, and athermally insulated housing covers at least a portion of the heatconducting block between the proximal and distal ends of this block. Inoperation, the first heatsink is located in the first temperature zone,at least a portion of the heat conducting block and the thermallyinsulated housing extend through the wall opening, and the secondheatsink is located in the second temperature zone. The above describedmodular thermoelectric cooling/heating unit can be used in a modularcooling system for retrofit into an existing refrigeration unit.

U.S. Pat. No. 7,382,047 for heat dissipation device by inventors Chen etal., filed Dec. 27, 2005 and issued Jun. 3, 2008, is directed to a heatdissipation device (1) includes a heat sink (10), a fan (20), and acooling member (30). The heat sink includes a base, a plurality of finsextending from the base and at least one heat pipe thermally connectingthe base and the fins. The cooling member is provided with a finassembly thereon and includes a cold surface attached to one side of thefins and a condensing portion of the at least one heat pipe to make theone side of the fins and the condensing portion have a lowertemperature.

U.S. Publication No. 20100293715 for temperature-controlled aircirculation type bedding by inventors Sakamoto et al., filed Oct. 21,2008 and published Nov. 25, 2010, is directed to temperature-controlledair circulation type bedding which introduces the blowoff air generatedby temperature control unit into an air flow passage provided around abedding body so as to cool or warm the body of a person in the bedding,controls the blowoff air temperature to form a comfortable sleepingenvironment irrespective of an external atmosphere temperature,suppresses discharge of carbon dioxide gas, etc. with a compactconfiguration, and has low power consumption. The temperature-controlledair circulation type bedding includes a temperature control unit 2 whichcontrols the blowoff air temperature by a cooling or heating action, anda bedding body 3 which provides an air flow passage 27 which allows theblowoff air from the temperature control unit to be introduced andcirculated therethrough, and cools or warms the inside thereof. Thetemperature of air which circulates through the bedding is detected sothat the temperature of the blowoff air is controlled by the temperaturecontrol unit.

U.S. Pat. No. 5,448,788 for thermoelectric cooling-heating mattress byinventor Wu, filed Mar. 8, 1994 and issued Sep. 12, 1995, is directed toa thermostat controlled mattress includes a mattress unit having anunderlay, a surface cover and a curved circuit. A water circuit tubeconnects to the curved circuit so as to allow water to be introducedinto the mattress unit with the aid of a pump. Water is circulatedbetween the mattress unit and a water storage box via the water circuittube. A sensor is operatively arranged with respect to the water storagebox to sense the temperature and quantity of water contained in thewater storage box and sends a signal to a thermostat electric circuit.An aluminum reservoir for the water is connected to the curved circuitof the mattress unit and the water circuit tube. A thermoelectricelement is connected to the reservoir and the power supply to heat orcool the water. Water is circulated in the water circuit tube betweenthe curved circuit of the mattress unit and the water storage box,through the reservoir. The water temperature is controlled based onsignals generated by the thermostat electric circuit, which activatesthe power supply operatively connected to the thermoelectric element. Aheat sink and a fan may be arranged adjacent to the thermoelectricelement such that the fan blows a current of air onto the heat sink.

U.S. Pat. No. 9,044,101 for climate controlled sleeping space byinventors Garcia et al., filed Mar. 13, 2013 and issued Jun. 2, 2015, isdirected to an apparatus includes a frame forming a sleeping space. Theapparatus includes a climate control system connected to the frame, theclimate control system having a hot side and a cold side, wherein thecold side is positioned toward the sleeping space. The apparatusincludes an insulating canopy supported by the frame. The insulatingcanopy includes an outer layer, a separator layer, a reflective layer,and an inner layer. The separator layer provides an air cavity thatreduces conductive heat transfer between the surface layer and thereflective layer.

U.S. Pat. No. 7,041,049 for sleep guidance system and related methods byinventor Raniere, filed Nov. 21, 2003 and issued May 9, 2006, isdirected to a sleep efficiency monitor and methods for pacing andleading a sleeper through an optimal sleep pattern. Embodiments of thepresent invention include a physiological characteristic monitor formonitoring the sleep stages of a sleeper, a sensory stimulus generatorfor generating stimulus to affect the sleep stages of a sleeper, and aprocessor for determining what sleep stage the sleeper is in and whatsensory stimulus is needed to cause the sleeper to move to another sleepstage. A personalized sleep profile may also be established for thesleeper and sleep guided in accordance with the profile parameters tooptimize a sleep session. By providing sensory stimulus to a sleeper,the sleeper may be guided through the various sleep stages in an optimalpattern so that the sleeper awakens refreshed even if sleep is disruptedduring the night or the sleeper's allotted sleep period is differentthan usual. Embodiments of the invention also involve calibration of thesleep guidance system to a particular sleeper.

U.S. Publication No. 20060293602 for sleep management device by inventorClark, filed Apr. 8, 2004 and published Dec. 28, 2006, is directed to ashort sleep/nap management apparatus and method. The apparatus hassensor means to detect one or more physiological parameters associatedwith a transition in sleep stages from wakefulness, processing means toprocess the parameters to determine when the transition is reached andstart the timer to run for a predetermined period, and alarm means toactuate at the end of said predetermined period to awaken the user.

U.S. Publication No. 20060293608 for device for and method of predictinga user's sleep state by inventors Rothman et al., filed Feb. 28, 2005and published Dec. 28, 2006, is directed to a device and a method forwaking a user in a desired sleep state. The device may predict anoccurrence when the user will be in the desired sleep state, such aslight sleep, and wake the user during that predicted occurrence. In oneembodiment, a user may set a wake-up time representing the latestpossible time that the user would like to be awakened. The occurrenceclosest to the wake-up time when the user will be in light sleep may bepredicted, thereby allowing the user to sleep as long as possible, whileawakening in light sleep. To predict when the user will be in thedesired sleep state, the user's sleep state may be monitored during thenight or sleep experience and the monitored information may be used inpredicting when the user will be in the desired sleep state.

U.S. Publication No. 20080234785 for sleep controlling apparatus andmethod, and computer program product thereof by inventors Nakayama etal., filed Sep. 13, 2007 and published Sep. 25, 2008, is directed to asleep controlling apparatus that includes a measuring unit that measuresbiological information of a subject; a first detecting unit that detectsa sleeping state of the subject selected from the group consisting of afalling asleep state, a REM sleep state, a light non-REM sleep state anda deep non-REM sleep state, based on the biological information measuredby the measuring unit; a first stimulating unit that applies a firststimulus of an intensity lower than a predetermined threshold value tothe subject when the light non-REM sleep state is detected by the firstdetecting unit; and a second stimulating unit that applies a secondstimulus of an intensity higher than the first stimulus after the firststimulus is applied to the subject.

U.S. Pat. No. 7,460,899 for apparatus and method for monitoring heartrate variability by inventor Almen, filed Feb. 25, 2005 and issued Dec.2, 2008, is directed to a wrist-worn or arm band worn heart ratevariability monitor. Heart rate variability (“HRV”) refers to thevariability of the time interval between heartbeats and is a reflectionof an individual's current health status. Over time, an individual mayuse the results of HRV tests to monitor either improvement ordeterioration of specific health issues. Thus, one use of the HRV testis as a medical motivator. When an individual has a poor HRV result, itis an indicator that they should consult their physician and makeappropriate changes where applicable to improve their health. If anindividual's HRV results deviate significantly from their normal HRV,they may be motivated to consult their physician. In addition, theinventive monitor is capable of monitoring the stages of sleep bychanges in the heart rate variability and can record the sleep (or rest)sessions with the resulting data accessible by the user or otherinterested parties. Alternate embodiments of the invention allowassistance in the diagnosis and monitoring of various cardiovascular andsleep breathing disorders and/or conditions. Other embodiments allowcommunication with internal devices such as defibrillators or drugdelivery mechanisms. Still other embodiments analyze HRV data to assistthe user in avoiding sleep.

U.S. Pat. No. 7,524,279 for sleep and environment control method andsystem by inventor Auphan, filed Dec. 29, 2004 and issued Apr. 28, 2009,is directed to a sleep system that includes sensors capable of gatheringsleep data from a person and environmental data during a sleep by theperson. A processor executes instructions that analyze this data andcontrol the sleep of the person and the environment surrounding theperson. Typically, the instructions are loaded in a memory where theyexecute to generate an objective measure of sleep quality from the sleepdata from the person and gather environmental data during the sleep bythe person. Upon execution, the instructions receive a subjectivemeasure of sleep quality from the person after the sleep, create a sleepquality index from the objective measure of sleep quality and subjectivemeasure of sleep quality, correlate the sleep quality index and acurrent sleep system settings with a historical sleep quality index andcorresponding historical sleep system settings. The instructions thenmay modify the current set of sleep system settings depending on thecorrelation between the sleep quality index and the historic sleepquality index. These sleep system settings control and potentiallychange one or more different elements of an environment associated withthe sleep system.

U.S. Publication No. 20090112069 for trend prediction device byinventors Kanamori et al., filed Sep. 25, 2008 and published Apr. 30,2009, is directed to a trend prediction device that is versatile andcapable of improving the accuracy of predicting a trend in a user'sphysical condition. The trend prediction device includes: a sensor-dataconverter configured to convert sensor data detected by a sleep sensorinto a sleep-related parameter for making a physical-data-trendjudgment; a parameter acquisition unit configured to acquire alifestyle-related parameter that indicates an action of the user duringa non-sleeping period, and possibly changing the physical-data trend;and a parameter comparator configured to compare the sleep-related andthe lifestyle-related parameters with respective reference parameters.The trend prediction device is configured to judge whether the physicaldata has an increase or a decrease in trend on the basis of thecomparison result of the sleep-related and the lifestyle-relatedparameters with their respective reference parameters.

U.S. Pat. No. 7,608,041 for monitoring and control of sleep cycles byinventor Sutton, filed Apr. 20, 2007 and issued Oct. 27, 2009, isdirected to a system including: a monitor for monitoring a user's sleepcycles; a processor which counts the sleep cycles to provide a sleepcycle count and which selects an awakening time according to a decisionalgorithm including the sleep cycle count as an input; and an alarm forawakening the user at the awakening time. Use of the sleep cycle countas an input to the decision algorithm advantageously enables a user tomore fully control and optimize his or her personal sleeping behavior.

U.S. Pat. No. 7,699,785 for method for determining sleep stages byinventor Nemoto, filed Feb. 23, 2005 and issued Apr. 20, 2010, isdirected to a method for determining sleep stages of an examinee,including detecting signals of the examinee with a biosignal detector,calculating a signal strength deviation value that indicates deviationof a signal strength of the detected signals, and determining a sleepstage by using the signal strength deviation value or a value of aplurality of values based on the signal strength deviation value as anindicator value.

U.S. Publication No. 20100100004 for skin temperature measurement inmonitoring and control of sleep and alertness by inventor van Someren,filed Dec. 15, 2008 and published Apr. 22, 2010, is directed to a methodof an arrangement for monitoring sleep in a subject by measuring withina prescribed interval skin temperature of a predetermined region of thesubject's body and a motion sensor for sensing motion of the subject,comparing the measured skin temperature of the predetermined region witha predetermined temperature threshold, and classifying the subject asbeing asleep or awake based on whether the skin temperature of thepredetermined region is above or below the temperature threshold and onthe motion data. In alternative aspects the invention relates to methodsof and arrangements for manipulating sleep, as well as monitoring ormanipulating alertness.

U.S. Pat. No. 7,868,757 for method for the monitoring of sleep using anelectronic device by inventors Radivojevic et al., filed Dec. 29, 2006and issued Jan. 11, 2011, is directed to a method where sleep sensorsignals are obtained to a mobile communication device from sensordevices. The mobile communication device checks the sleep sensor signalsfor a sleep state transition, determines the type of the sleep statetransition, forms control signals based on the type of the sleep statetransition and sends the control signals to at least one electronicdevice.

U.S. Publication No. 20110015495 for method and system for managing auser's sleep by inventors Dothie et al., filed Jul. 16, 2010 andpublished Jan. 20, 2011, is directed to a sleep management method andsystem for improving the quality of sleep of a user which monitors oneor more objective parameters relevant to sleep quality of the user whenin bed and receives from the user in waking hours via a portable devicesuch as a mobile phone feedback from objective test data on cognitiveand/or psychomotor performance.

U.S. Publication No. 20110230790 for method and system for sleepmonitoring, regulation and planning by inventor Kozlov, filed Mar. 27,2010 and published Sep. 22, 2011, is directed to a method for operatinga sleep phase actigraphy synchronized alarm clock that communicates witha remote sleep database, such as an internet server database, andcompares user physiological parameters, sleep settings, and actigraphydata with a large database that may include data collected from a largenumber of other users with similar physiological parameters, sleepsettings, and actigraphy data. The remote server may use “black box”analysis approach by running supervised learning algorithms to analyzethe database, producing sleep phase correction data which can beuploaded to the alarm clock, and be used by the alarm clock to furtherimprove its REM sleep phase prediction accuracy.

U.S. Publication No. 20110267196 for system and method for providingsleep quality feedback by inventors Hu et al., filed May 3, 2011 andpublished Nov. 3, 2011, is directed to a system and method for providingsleep quality feedback that includes receiving alarm input on a basedevice from a user; the base device communicating an alarm setting basedon the alarm input to an individual sleep device; the individual sleepdevice collecting sleep data based on activity input of a user; theindividual sleep device communicating sleep data to the base device; thebase device calculating sleep quality feedback from the sleep data;communicating sleep quality feedback to a user; and the individual sleepdevice activating an alarm, wherein activating the alarm includesgenerating tactile feedback to the user according to the alarm setting.

U.S. Pat. No. 8,179,270 for methods and systems for providing sleepconditions by inventors Rai et al., filed Jul. 21, 2009 and issued May15, 2012, is directed to a method for monitoring a sleep condition witha sleep scheduler wherein the method includes receiving a sleepparameter via an input receiver on the sleep scheduler. The methodfurther includes associating the sleep parameter with an overallalertness and outputting a determined sleep condition based on theoverall alertness. A system for providing a sleep condition is furtherdisclosed therein the system comprising includes a display, an inputreceiver operable to receive a sleep parameter, and a processor incommunication with the display. The processor may be operable todetermine an overall alertness associated with the sleep parameter andwherein the processor is operable to output a determined sleep conditionbased on the overall alertness.

U.S. Pat. No. 8,290,596 for therapy program selection based on patientstate by inventors Wei et al., filed Sep. 25, 2008 and issued Oct. 16,2012, is directed to selecting a therapy program based on a patientstate, where the patient state comprises at least one of a movementstate, sleep state or speech state. In this way, therapy delivery istailored to the patient state, which may include specific patientsymptoms. The therapy program is selected from a plurality of storedtherapy programs that comprise therapy programs associated with arespective one at least two of the movement, sleep, and speech states.Techniques for determining a patient state include receiving volitionalpatient input or detecting biosignals generated within the patient'sbrain. The biosignals are nonsymptomatic and may be incidental to themovement, sleep, and speech states or generated in response tovolitional patient input.

U.S. Publication No. 20120296402 for device and method for brown adiposetissue activation by inventor Kotter, filed May 17, 2011 and publishedNov. 22, 2012, is directed to devices and methods of activating brownadipose tissue. One method comprises applying a cooling device on asubject at a supraclavicular region or paravertebral region of skinoverlying brown adipose tissue; and maintaining the cooling device incontact with the skin at a temperature from 45° F. to 70° F. for aduration of at least 90 minutes so as to cool the region sufficiently toactivate the brown adipose tissue.

U.S. Pat. No. 8,348,840 for device and method to monitor, assess andimprove quality of sleep by inventors Heit et al., filed Feb. 4, 2010and issued Jan. 8, 2013, is directed to a medical sleep disorderarrangement that integrates into current diagnosis and treatmentprocedures to enable a health care professional to diagnose and treat aplurality of subjects suffering from insomnia. The arrangement mayinclude both environmental sensors and body-worn sensors that measurethe environmental conditions and the condition of the individualpatient. The data may be collected and processed to measure clinicallyrelevant attributes of sleep quality automatically. These automaticallydetermined measures, along with the original sensor data, may beaggregated and shared remotely with the health care professional. Acommunication apparatus enables the healthcare professional to remotelycommunicate with and further assess the patient and subsequentlyadminister the treatment. Thus, a more accurate diagnosis and moreeffective treatment is provided while reducing the required cliniciantime per patient for treatment delivery.

U.S. Pat. No. 8,529,457 for system and kit for stress and relaxationmanagement by inventors Devot et al., filed Feb. 16, 2009 and issuedSep. 10, 2013, is directed to a system and a kit for stress andrelaxation management. A cardiac activity sensor is used for measuringthe heart rate variability (HRV) signal of the user and a respirationsensor for measuring the respiratory signal of the user. The systemcontains a user interaction device having an input unit for receivinguser specific data and an output unit for providing information outputto the user. A processor is used to assess the stress level of the userby determining a user related stress index. The processor is also usedto monitor the user during a relaxation exercise by means of determininga relaxation index based on the measured HRV and respiratory signals,the relaxation index being continuously adapted to the incoming measuredsignals and based thereon the processor instructs the output unit toprovide the user with biofeedback and support messages. Finally, theprocessor uses the user specific data as an input in generating a firstset of rules defining an improvement plan for self-management of stressand relaxation. The first set of rules is adapted to trigger commandsinstructing the output unit to provide the user with motivation relatedmessages. Also, at least a portion of said user specific data is furtherused to define a second set of rules indicating the user's personalgoals.

U.S. Pat. No. 9,459,597 for method and apparatus to provide an improvedsleep experience by selecting an optimal next sleep state for a user byinventors Kahn et al., filed Feb. 28, 2013 and issued Oct. 4, 2016, isdirected to a sleep sensing system comprising a sensor to obtainreal-time information about a user, a sleep state logic to determine theuser's current sleep state based on the real-time information. Thesystem further comprising a sleep stage selector to select an optimalnext sleep state for the user, and a sound output system to outputsounds to guide the user from the current sleep state to the optimalnext sleep state.

U.S. Pat. No. 8,768,520 for systems and methods for controlling abedroom environment and for providing sleep data by inventors Oexman etal., filed Nov. 14, 2008 and issued Jul. 1, 2014, is directed to asystem for controlling a bedroom environment that includes anenvironmental data collector configured to collect environmental datarelating to the bedroom environment; a sleep data collector configuredto collect sleep data relating to a person's state of sleep; an analysisunit configured to analyze the collected environmental data and thecollected sleep data and to determine an adjustment of the bedroomenvironment that promotes sleep of the person; and a controllerconfigured to effect the adjustment of the bedroom environment. A methodfor controlling a bedroom environment includes collecting environmentaldata relating to the bedroom environment; collecting sleep data relatingto a person's state of sleep; analyzing the collected environmental dataand the collected sleep data; determining an adjustment to the bedroomenvironment that promotes sleep; and communicating the adjustment to adevice that effects the bedroom environment.

U.S. Publication No. 20140277308 for adaptive thermodynamic therapysystem by inventors Cronise et al., filed Mar. 17, 2014 and publishedSep. 18, 2014, is directed to an adaptive thermodynamic therapy systemcapable of comfortably increasing metabolic expenditure to facilitateexcess weight loss, including one or more sensors for measuring asubject user's body temperature, current activity/metabolic level andproviding data representative of said body temperature to acomputer-based controller, and then actively controlling a thermal loadin contact with subject user's body and responsive to the computer-basedcontroller. In one embodiment, the controller is configured to receiveinput from at least one computer-based device configured to provide userbody data and calculate a state value representative of the user bodydata and to adjust the thermal load to obtain a desired physiologicalresponse from the user by modifying the state values.

U.S. Pat. No. 9,186,479 for methods and systems for gathering humanbiological signals and controlling a bed device by inventorsFranceschetti et al., filed Jun. 5, 2015 and issued Nov. 17, 2015, isdirected to methods and systems for an adjustable bed device configuredto: gather biological signals associated with multiple users, such asheart rate, breathing rate, or temperature; analyze the gathered humanbiological signals; and heat or cool a bed based on the analysis.

U.S. Pat. No. 10,376,670 for methods and systems for sleep management byinventors Shouldice et al., filed Dec. 21, 2015 and issued Aug. 13,2019, is directed to a processing system including methods to promotesleep. The system may include a monitor such as a non-contact motionsensor from which sleep information may be determined. User sleepinformation, such as sleep stages, hypnograms, sleep scores, mindrecharge scores and body scores, may be recorded, evaluated and/ordisplayed for a user. The system may further monitor ambient and/orenvironmental conditions corresponding to sleep sessions. Sleep advicemay be generated based on the sleep information, user queries and/orenvironmental conditions from one or more sleep sessions. Communicatedsleep advice may include content to promote good sleep habits and/ordetect risky sleep conditions. In some versions of the system, any oneor more of a bedside unit sensor module, a smart processing device, suchas a smart phone or smart device, and network servers may be implementedto perform the methodologies of the system.

U.S. Pat. No. 10,599,116 for methods for enhancing wellness associatedwith habitable environments by inventors Pillai et al., filed Aug. 26,2016 and issued Mar. 24, 2020, is directed to controlling environmentalcharacteristics of habitable environments (e.g., hotel or motel rooms,spas, resorts, cruise boat cabins, offices, hospitals and/or homes,apartments or residences) to eliminate, reduce or ameliorate adverse orharmful aspects and introduce, increase or enhance beneficial aspects inorder to improve a “wellness” or sense of “wellbeing” provided via theenvironments. Control of intensity and wavelength distribution ofpassive and active illumination addresses various issues, symptoms orsyndromes, for instance to maintain a circadian rhythm or cycle, adjustfor “jet lag” or season affective disorder, etc. Air quality andattributes are controlled. Scent(s) may be dispersed. Noise is reducedand sounds (e.g., masking, music, natural) may be provided.Environmental and biometric feedback is provided. Experimentation andmachine learning are used to improve health outcomes and wellnessstandards.

U.S. Publication No. 20170231812 for method, device and system formodulating an activity of brown adipose tissue in a vertebrate subjectby inventors Boyden et al., filed May 4, 2017 and published Aug. 17,2017, is directed to devices, systems, and methods for treatment of adisease, disorder, or condition in a vertebrate subject. A device isprovided that includes one or more cooling elements configured to beapplied to one or more tissues of a vertebrate subject to modulate atleast one activity of brown adipose tissue of the vertebrate subject,and a programmable controller configured to provide instructions to theone or more cooling elements in response to information regarding one ormore physiological conditions of the vertebrate subject.

U.S. Pat. No. 9,750,415 for heart rate variability with sleep detectionby inventors Breslow et al., filed Jul. 12, 2016 and issued Sep. 5,2017, is directed to a system using continuous tracking of sleepactivity and heart rate activity to evaluate heart rate variabilityimmediately before transitioning to an awake state, e.g., at the end ofthe last phase of deep sleep. In particular, a wearable, continuousphysiological monitoring system includes one or more sensors to detectsleep states, the transitions between sleep states, and the transitionsfrom a sleep state to an awake state for a user. This information can beused in conjunction with continuously monitored heart rate data tocalculate heart rate variability of the user at the end of the lastphase of sleep preceding the user waking up. By using the history ofheart rate data in conjunction with sleep activity in this manner, anaccurate and consistent recovery score can be calculated based on heartrate variability.

U.S. Pat. No. 10,368,797 for system for monitoring sleep efficiency byinventor Huang, filed May 7, 2018 and issued Aug. 6, 2019, is directedto a system for monitoring sleep efficiency includes a measuring deviceand a data processing device. The measuring device is for measuring bodytemperature of a subject and for outputting temperature data associatedwith the body temperature. The data processing device receives thetemperature data, and is programmed to process the temperature data soas to determine sleep efficiency. The processing of the temperature dataincludes constructing a curve of the body temperature over asleepepisode, finding a saddle point of the curve occurring for a first time,treating a time instance at which the saddle point occurs as asleep-onset time point at which the subject falls asleep, anddetermining the sleep efficiency according to the sleep-onset timepoint.

U.S. Publication No. 20180344517 for methods and apparatuses for thethermal treatment of neurologic and psychiatric disorders by inventorNofzinger, filed Jun. 6, 2018 and published Dec. 6, 2018, is directed tomethod and apparatuses for applying region cooling to modulate theautonomic nervous system (and particularly the parasympathetic nervoussystems) to treat a medical disorder. Described herein are methods andapparatuses for modulating a patient's parasympathetic nervous system bysimulating a diving reflex using localized cooling.

SUMMARY OF THE INVENTION

This invention relates broadly and generally to articles, methods, andsystems for exchanging heat with a circulating fluid, and specificallyto articles, methods, and system for exchanging heat with a fluid usedto heat or cool a mattress pad.

One embodiment of the present invention is directed to a system forcooling a fluid, including a control unit including at least onethermoelectric module connected to a fluid reservoir, containing thefluid, at least one heat pipe connecting the at least one thermoelectricmodule with a plurality of heat sinks, at least one fan attached to eachof the plurality of heat sinks, and an electromagnetic field (EMF)shield, wherein the EMF shield is operable to reduce the strength of theEMF produced by the control unit, wherein the plurality of heat sinksare aligned along a central axis.

Another embodiment of the present invention is directed to a system forcooling a fluid, including a control unit including at least onethermoelectric module connected to a fluid reservoir, containing thefluid, at least one heat pipe connecting the at least one thermoelectricmodule with a plurality of heat sinks, at least one fan attached to eachof the plurality of heat sinks, and an electromagnetic field (EMF)shield, wherein the EMF shield is operable to reduce the strength of theEMF produced by the control unit, wherein the plurality of heat sinksare aligned along a central axis, and a bedding device having fluidchannels therein, wherein the control unit is operable to pump the fluidfrom the fluid reservoir into the bedding device.

Yet another embodiment of the present invention is directed to a systemfor cooling a fluid, including a control unit including at least onethermoelectric module connected to a fluid reservoir, containing thefluid, a plurality of heat sinks connected to the at least onethermoelectric module, at least one fan attached to each of theplurality of heat sinks, and an electromagnetic field (EMF) shield,wherein the EMF shield is operable to reduce the strength of the EMFproduced by the control unit, wherein the plurality of heat sinks arealigned along a central axis, and wherein each of the at least one fanattached to each of the plurality of heat sinks are operable to blow orsuck air to or from the plurality of heat sinks in a single direction.

These and other aspects of the present invention will become apparent tothose skilled in the art after a reading of the following description ofthe preferred embodiment when considered with the drawings, as theysupport the claimed invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates the effects of a stressor on the body.

FIG. 2 is a block diagram of one embodiment of a stress reduction andsleep promotion system.

FIG. 3 is an environmental perspective view of a temperature-regulatedmattress pad having two surface temperature zones connected torespective thermoelectric control units according to one exemplaryembodiment of the present invention.

FIG. 4 is a perspective view of the exemplary control unit demonstratingthe quick connection/disconnection of the flexible fluid supply andreturn lines.

FIG. 5 is a side schematic view showing various internal components of acontrol unit fluidly connected to the mattress pad according to oneembodiment of the present invention.

FIG. 6 is a top schematic view of a control unit according to oneembodiment of the present invention.

FIG. 7 illustrates the difference between structured water andunstructured water.

FIG. 8A illustrates one embodiment of a mattress pad with threeindependent temperature zones.

FIG. 8B illustrates one embodiment of a double mattress pad with threeindependent temperature zones for both users.

FIG. 8C illustrates one embodiment of a mattress pad with threeindependent temperature zones connected to at least one remote device.

FIG. 9A illustrates a cross-section of a mattress pad with two layers ofwaterproof material.

FIG. 9B illustrates a cross-section of a mattress pad with two layers ofwaterproof material and two layers of a second material.

FIG. 9C illustrates a cross-section of a mattress pad with two layers ofwaterproof material and a spacer layer.

FIG. 9D illustrates a cross-section of a mattress pad with two layers ofwaterproof material, two layers of a second material, and a spacerlayer.

FIG. 10 is a view of a mattress pad hose elbow according to oneembodiment.

FIG. 11 is another view of the mattress pad hose elbow of FIG. 10.

FIG. 12 is an exploded view of a single mattress pad.

FIG. 13 is a top perspective view of a single mattress pad.

FIG. 14 is a top perspective view of an end of a single mattress pad.

FIG. 15 is a side perspective view of an end of a single mattress pad.

FIG. 16 is a top perspective view of a double mattress pad.

FIG. 17 is an exploded view of a double mattress pad.

FIG. 18 is another top perspective view of a double mattress pad.

FIG. 19 is a view of the corner of a double mattress pad.

FIG. 20 is another view of the corner of a double mattress pad.

FIG. 21 is a view of another embodiment of a mattress pad.

FIG. 22 is a graph of total heat transfer rate vs. bulk watertemperature.

FIG. 23 is a graph of a human heat transfer rate vs. bulk watertemperature.

FIG. 24 illustrates a comparison between several differentthermoelectric cooler (TEC) configurations.

FIG. 25 is three-dimensional graph showing the total thermoelectriccooler (TEC) capacity vs. the heat sink thermal resistance vs. themaximum system cooling power for three configurations.

FIG. 26 is a block diagram of one embodiment of the system architecture.

FIG. 27 is an illustration of a network of stress reduction and sleeppromotion systems.

FIG. 28 is a diagram illustrating an example process for monitoring astress reduction and sleep promotion system and updating a virtual modelbased on monitored data.

FIG. 29 is a table of average deep sleep percentages by age.

FIG. 30 is a table of target deep sleep percentages by age.

PRIOR ART FIG. 31 illustrates a body with a core and a shell both in acold environment and a warm environment.

PRIOR ART FIG. 32 illustrates mechanisms of heat loss of the body.

PRIOR ART FIG. 33 illustrates a decrease in core body temperature duringa sleep period.

PRIOR ART FIG. 34 illustrates the thermal neutral zone.

PRIOR ART FIG. 35 is a table of resting heart rates for men and women.

PRIOR ART FIG. 36 is an optimal heart rate curve during sleep.

PRIOR ART FIG. 37 is a graph of normal heart rate variability (HRV)values versus age and sex.

FIG. 38A illustrates a hypnogram of one sleep cycle prior to cooling.

FIG. 38B illustrates a hypnogram of one sleep cycle after cooling.

FIG. 39 illustrates a hypnogram of a sleeping period.

FIG. 40 shows a schematic diagram illustrating general components of acloud-based computer system.

FIG. 41 illustrates top transparent view of a heat sink arrangement in acontrol unit according to one embodiment of the present invention.

FIG. 42 illustrates an orthogonal, transparent side view of the heatsink arrangement in the control unit shown in FIG. 41.

FIG. 43 illustrates an isometric view of the heat sink arrangement shownin FIG. 41.

FIG. 44 is a section view of a control unit for a climate-control systemaccording to one embodiment of the present invention.

FIG. 45 is an isometric section view of a control unit for aclimate-control system according to one embodiment of the presentinvention.

FIG. 46 is an isometric section view of a control unit for aclimate-control system according to one embodiment of the presentinvention.

DETAILED DESCRIPTION

The present invention is generally directed to articles, methods, andsystems for non-shivering thermogenesis to enhance sleep recovery and/orpromote weight loss.

Several studies show a link between stress and illness. Stress may causephysiological changes and lead individuals to adopt health damagingbehaviors (e.g., smoking, drinking, poor nutrition, lack of physicalactivity). These physiological changes and health damaging behaviors cancause illnesses, such as sleep disturbances, impaired wound healing,increased infections, heart disease, diabetes, ulcers, pain, depression,and obesity or weight gain.

The body reacts to stress through two systems: the autonomic nervoussystem and the hypothalamic-pituitary-adrenal (HPA) axis. The autonomicnervous system, which consists of the sympathetic nervous system and theparasympathetic nervous system, is responsible for reacting to shortterm (“acute”) stress. In response to short term stress, the sympatheticnervous system activates the “fight or flight response” through thesympathoadrenal medullary (SAM) axis. This causes the adrenal medulla tosecrete catecholamines (e.g., epinephrine and norepinephrine), whichcauses blood glucose levels to rise, blood vessels to constrict, heartrate to increase, and blood pressure to rise. Blood is diverted fromnonessential organs to the heart and skeletal muscles, which leads todecreased digestive system activity and reduced urine output.Additionally, the metabolic rate increases and bronchioles dilate. Theparasympathetic nervous system then returns the body to homeostasis.

The HPA axis is responsible for reacting to long term (“chronic”)stress. This causes the adrenal cortex to secrete steroid hormones(e.g., mineralocorticoids and glucocorticoids). Mineralocorticoids(e.g., aldosterone) cause retention of sodium and water by the kidneys,increased blood pressure, and increased blood volume. Glucocorticoids(e.g., cortisol) cause proteins and fats to be converted to glucose orbroken down for energy, increased blood glucose, and suppression of theimmune system.

Thus, stress impacts the body on a cellular level and is a precursor tomany disease states. Therefore, it is important to manage and treatstress to maintain health. However, as a result of modern lifestyles,most people are busy, tired, and stressed out. Most people also lack thetime and energy to obtain treatments for minor ailments or treatments toprevent disease. What is needed is a convenient treatment that reducesstress and inflammation and promotes healing.

Energy medicine (e.g., biofield therapies, bioelectromagnetic therapies,acupuncture, homeopathy) focuses on the principle that small changesrepeated over time can change the dynamics of the body and stimulatehealing. The present invention utilizes that principle to reduce stress,promote sleep, and stimulate healing. Further, the present inventionreduces stress and stimulates healing while a user is resting orsleeping, which is convenient for the user and allows a focused time(e.g., 6-9 hours during a sleeping period) for the user to heal while athome.

Referring now to the drawings in general, the illustrations are for thepurpose of describing a preferred embodiment of the invention and arenot intended to limit the invention thereto.

FIG. 1 illustrates the effects of a stressor on the body. The bodyreleases catecholamines or steroid hormones as a physiological responseto the stressor. Stress may also lead individuals to adopt healthdamaging behaviors (e.g., smoking, drinking, poor nutrition, lack ofphysical activity). This may lead to illnesses, such as sleepdisturbances, impaired wound healing, increased infections, heartdisease, diabetes, ulcers, pain, depression, anxiety, and/or obesity orweight gain. These illnesses themselves may become a stressor, whichtriggers the cycle to continue and causes further physical and mentalproblems.

FIG. 2 is a block diagram of one embodiment of the stress reduction andsleep promotion system. The stress reduction and sleep promotion system700 includes body sensors 702, environmental sensors 704, a remotedevice 511 with local storage 706, a remote server 708, and systemcomponents 710. The body sensors 702 include a posture sensor 711, arespiration sensor 712, an electrooculography (EOG) sensor 713, a heartsensor 714, a body weight sensor 715, a movement sensor 716, anelectromyography (EMG) sensor 717, a brain wave sensor 718, a bodytemperature sensor 720, an analyte sensor 721, a pulse oximeter sensor722, a blood pressure (BP) sensor 723, an electrodermal activity (EDA)sensor 724, and/or a body fat sensor 725. In one embodiment, at leastone body sensor 702 is implanted in the body of a user. In a preferredembodiment, at least one body sensor 702 is operable to transmit data tothe remote device 511 and/or the remote server 708 in real time.

The posture sensor 711 measures a posture of an individual. In oneembodiment, the posture sensor 711 includes at least one pressuresensor. The at least one pressure sensor is preferably embedded in aseat and/or seat cushion (e.g., DARMA, SENSIMAT). In another embodiment,the posture sensor 711 is a wearable device (e.g., LUMOback PostureSensor). In another embodiment, the posture sensor 711 includes at leastone camera. The at least one camera is operable to detect a posture ofthe individual using, e.g., computer vision.

The respiration sensor 712 measures a respiratory rate. In oneembodiment, the respiration sensor 712 is incorporated into a wearabledevice (e.g., a chest strap). In another embodiment, the respirationsensor 712 is incorporated into a patch or a bandage. Alternatively, therespiratory rate is estimated from an electrocardiogram, aphotoplethysmogram (e.g., a pulse oximeter), and/or an accelerometer. Inyet another embodiment, the respiratory sensor 712 uses a non-contactmotion sensor to monitor respiration.

The electrooculography (EOG) sensor 713 measures the corneo-retinalstanding potential that exists between the front and the back of theeye. Measurements of eye movements are done by placing pairs ofelectrodes either above and below the eye or to the left and right ofthe eye. If the eye moves to a position away from the center and towardone of the electrodes, a potential difference occurs between theelectrodes. The recorded potential is a measure of the eye's position.

The heart sensor 714 is preferably incorporated into a wearable device(e.g., Apple Watch®, Fitbit®, Jawbone®). Alternatively, the heart sensor714 is attached to the user with a chest strap. In another embodiment,the heart sensor 714 is incorporated into a patch or a bandage. In yetanother embodiment, the heart sensor 714 is incorporated into a sensordevice on or under the mattress (e.g., Beddit®, Emfit® QS™). A heartrate is determined using electrocardiography, pulse oximetry,ballistocardiography, or seismocardiography. In one embodiment, theheart sensor 714 measures heart rate variability (HRV). HRV is ameasurement of the variation in time intervals between heartbeats. Ahigh HRV measurement is indicative of less stress, while a low HRVmeasurement is indicative of more stress. Studies have linkedabnormalities in HRV to diseases where stress is a factor (e.g.,diabetes, depression, congestive heart failure). In one embodiment, aPoincaré plot is generated to display HRV on a device such as asmartphone. In another embodiment, the heart sensor 714 is anelectrocardiogram.

The body weight sensor 715 is preferably a smart scale (e.g., Fitbit®Aria®, Nokia® Body+, Garmin® Index™, Under Armour® Scale, PivotalLiving® Smart Scale, iHealth® Core). Alternatively, the body weightsensor 715 is at least one pressure sensor embedded in a mattress or amattress topper. In one embodiment, the stress reduction and sleeppromotion system 700 is also operable to determine a height of a userusing the at least one pressure sensor embedded in a mattress or amattress topper. In another embodiment, a body mass index (BMI) of theuser is calculated using the body weight of the user and the height ofthe user as measured by the at least one pressure sensor.

The movement sensor 716 is an accelerometer and/or a gyroscope. In oneembodiment, the accelerometer and/or the gyroscope are incorporated intoa wearable device (e.g., Fitbit®, Jawbone®, actigraph). In anotherembodiment, the accelerometer and/or the gyroscope are incorporated intoa smartphone. In alternative embodiment, the movement sensor 716 is anon-contact sensor. In one embodiment, the movement sensor 716 is atleast one piezoelectric sensor. In another embodiment, the movementsensor 716 is a pyroelectric infrared sensor (i.e., a “passive” infraredsensor). In yet another embodiment, the movement sensor 716 is at leastone pressure sensor embedded in a mattress or mattress topper.Alternatively, the movement sensor 716 is incorporated into a smartfabric. In still another embodiment, the movement sensor 716 is operableto analyze a gait of a user.

The electromyography (EMG) sensor 717 records the electrical activityproduced by skeletal muscles. Impulses are recorded by attachingelectrodes to the skin surface over the muscle. In a preferredembodiment, three electrodes are placed on the chin. One in the frontand center and the other two underneath and on the jawbone. Theseelectrodes demonstrate muscle movement during sleep, which can be usedto detect REM or NREM sleep. In another embodiment, two electrodes areplaced on the inside of each calf muscle about 2 to 4 cm (about 0.8 to1.6 inches) apart. In yet another embodiment, two electrodes are placedover the anterior tibialis of each leg. The electrodes on the leg can beused to detect movement of the legs during sleep, which may occur withRestless Leg Syndrome or Periodic Limb Movements of Sleep.

The brain wave sensor 718 is preferably an electroencephalogram (EEG)with at least one channel. In a preferred embodiment, the EEG has atleast two channels. Multiple channels provide higher resolution data.The frequencies in EEG data indicate particular brain states. The brainwave sensor 718 is preferably operable to detect delta, theta, alpha,beta, and gamma frequencies. In another embodiment, the brain wavesensor 718 is operable to identify cognitive and emotion metrics,including focus, stress, excitement, relaxation, interest, and/orengagement. In yet another embodiment, the brain wave sensor 718 isoperable to identify cognitive states that reflect the overall level ofengagement, attention and focus and/or workload that reflects cognitiveprocesses (e.g., working memory, problem solving, analytical reasoning).

The energy field sensor 719 measures an energy field of a user. In oneembodiment, the energy field sensor 719 is a gas discharge visualization(GDV) device. Examples of a GDV device are disclosed in U.S. Pat. Nos.7,869,636 and 8,321,010 and U.S. Publication No. 20100106424, each ofwhich is incorporated herein by reference in its entirety. The GDVdevice utilizes the Kirlian effect to evaluate an energy field. In apreferred embodiment, the GDV device utilizes a high-intensity electricfield (e.g., 1024 Hz, 10 kV, square pulses) input to an object (e.g.,human fingertips) on an electrified glass plate. The high-intensityelectric field produces a visible gas discharge glow around the object(e.g., fingertip). The visible gas discharge glow is detected by acharge-coupled detector and analyzed by software on a computer. Thesoftware characterizes the pattern of light emitted (e.g., brightness,total area, fractality, density). In a preferred embodiment, thesoftware utilizes Mandel's Energy Emission Analysis and the Su-Joksystem of acupuncture to create images and representations of bodysystems. The energy field sensor 719 is preferably operable to measurestress levels, energy levels, and/or a balance between the left andright sides of the body.

The body temperature sensor 720 measures core body temperature and/orskin temperature. The body temperature sensor 720 is a thermistor, aninfrared sensor, or thermal flux sensor. In one embodiment, the bodytemperature sensor 720 is incorporated into an armband or a wristband.In another embodiment, the body temperature sensor 720 is incorporatedinto a patch or a bandage. In yet another embodiment, the bodytemperature sensor 720 is an ingestible core body temperature sensor(e.g., CorTemp®). The body temperature sensor 720 is preferablywireless.

The analyte sensor 721 monitors levels of an analyte in blood, sweat, orinterstitial fluid. In one embodiment, the analyte is an electrolyte, asmall molecule (molecular weight <900 Daltons), a protein (e.g.,C-reactive protein), and/or a metabolite. In another embodiment, theanalyte is glucose, lactate, glutamate, oxygen, sodium, chloride,potassium, calcium, ammonium, copper, magnesium, iron, zinc, creatinine,uric acid, oxalic acid, urea, ethanol, an amino acid, a hormone (e.g.,cortisol, melatonin), a steroid, a neurotransmitter, a catecholamine, acytokine, and/or an interleukin (e.g., IL-6). The analyte sensor 721 ispreferably non-invasive. Alternatively, the analyte sensor 721 isminimally invasive or implanted. In one embodiment, the analyte sensor721 is incorporated into a wearable device. Alternatively, the analytesensor 721 is incorporated into a patch or a bandage.

The pulse oximeter sensor 722 monitors oxygen saturation. In oneembodiment, the pulse oximeter sensor 722 is worn on a finger, a toe, oran ear. In another embodiment, the pulse oximeter sensor 722 isincorporated into a patch or a bandage. The pulse oximeter sensor 722 ispreferably wireless. Alternatively, the pulse oximeter sensor 722 iswired. In one embodiment, the pulse oximeter sensor 722 is connected bya wire to a wrist strap or a strap around a hand. In another embodiment,the pulse oximeter sensor 722 is combined with a heart rate sensor 714.In yet another embodiment, the pulse oximeter sensor 722 uses a cameralens on a smartphone or a tablet.

The blood pressure (BP) sensor 723 is a sphygmomanometer. Thesphygmomanometer is preferably wireless. Alternatively, the bloodpressure sensor 723 estimates the blood pressure without an inflatablecuff (e.g., Salu™ Pulse+). In one embodiment, the blood pressure sensor723 is incorporated into a wearable device.

The electrodermal activity sensor 724 measures sympathetic nervoussystem activity. Electrodermal activity is more likely to have highfrequency peak patterns (i.e., “storms”) during deep sleep. In oneembodiment, the electrodermal activity sensor 724 is incorporated into awearable device. Alternatively, the electrodermal activity sensor 724 isincorporated into a patch or a bandage.

The body fat sensor 725 is preferably a bioelectrical impedance device.In one embodiment, the body fat sensor 725 is incorporated into a smartscale (e.g., Fitbit® Aria®, Nokia® Body+, Garmin® Index™, Under Armour®Scale, Pivotal Living® Smart Scale, iHealth® Core). Alternatively, thebody fat sensor 725 is a handheld device.

The environmental sensors 704 include an environmental temperaturesensor 726, a humidity sensor 727, a noise sensor 728, an air qualitysensor 730, a light sensor 732, a motion sensor 733, and/or a barometricsensor 734. In one embodiment, the environmental temperature sensor 726,the humidity sensor 727, the noise sensor 728, the air quality sensor730, the light sensor 732, the motion sensor 733, and/or the barometricsensor 734 are incorporated into a home automation system (e.g., Amazon®Alexa®, Apple® HomeKit™, Google® Home™, IF This Then That® (IFTTT®),Nest®). Alternatively, the environmental temperature sensor 726, thehumidity sensor 727, the noise sensor 728, and/or the light sensor 732are incorporated into a smartphone or tablet. In one embodiment, thenoise sensor 728 is a microphone. In one embodiment, the air qualitysensor 730 measures carbon monoxide, carbon dioxide, nitrogen dioxide,sulfur dioxide, particulates, and/or volatile organic compounds (VOCs).In another embodiment, at least one environmental sensor 704 is operableto transmit data to the remote device 511 and/or the remote server 708in real time.

The remote device 511 is preferably a smartphone or a tablet.Alternatively, the remote device 511 is a laptop or a desktop computer.The remote device 511 includes a processor 760, an analytics engine 762,a control interface 764, and a user interface 766. The remote device 511accepts data input from the body sensors 702 and/or the environmentalsensors 704. The remote device also accepts data input from the remoteserver 708. The remote device 511 stores data in a local storage 706.

The local storage 706 on the remote device 511 includes a user profile736, historical subjective data 738, predefined programs 740, customprograms 741, historical objective data 742, and historicalenvironmental data 744. The user profile 736 stores stress reduction andsleep promotion system preferences and information about the user,including but not limited to, age, weight, height, gender, medicalhistory (e.g., sleep conditions, medications, diseases), fitness (e.g.,fitness level, fitness activities), sleep goals, stress level, and/oroccupational information (e.g., occupation, shift information). Themedical history includes caffeine consumption, alcohol consumption,tobacco consumption, use of prescription sleep aids and/or othermedications, blood pressure, restless leg syndrome, narcolepsy,headaches, heart disease, sleep apnea, depression, stroke, diabetes,insomnia, anxiety or post-traumatic stress disorder (PTSD), and/orneurological disorders.

In one embodiment, the medical history incorporates information gatheredfrom the Epworth Sleepiness Scale (ESS), the Insomnia Severity Index(ISI), Generalized Anxiety Disorder 7-item (GAD-7) Scale, and/or PatientHeath Questionanaire-9 (PHQ-9) (assessment of depression). The ESS isdescribed in Johns M W (1991). “A new method for measuring daytimesleepiness: the Epworth sleepiness scale”, Sleep, 14 (6): 540-5, whichis incorporated herein by reference in its entirety. The ISI isdescribed in Morin et al. (2011). “The Insomnia Severity Index:Psychometric Indicators to Detect insomnia Cases and Evaluate TreatmentResponse”, Sleep, 34(5): 601-608, which is incorporated herein byreference in its entirety. The GAD-7 is described in Spitzer et al., “Abrief mean re for assessing generalized anxiety disorder: the GAD-7”,Arch Intern Med., 2006 May 22; 166(1):1092-7, which is incorporatedherein by reference in its entirety. The PHQ-9 is described in Kroenkeet al., “The PHQ-9: Validity of a Brief Depression Severity Measure”, J.Gen. Intern. Med., 2001 September; 16(9): 606-613, which is incorporatedherein by reference in its entirety.

In one embodiment, the weight of the user is automatically uploaded tothe local storage from a third-party application. In one embodiment, thethird-party application obtains the information from a smart scale(e.g., Fitbit® Aria®, Nokia® Body+™, Garmin® Index™, Under Armour®Scale, Pivotal Living® Smart Scale, iHealth® Core). In anotherembodiment, the medical history includes information gathered from aResting Breath Hold test.

The historical objective data 742 includes information gathered from thebody sensors 702. This includes information from the respiration sensor712, the electrooculography sensor 713, the heart rate sensor 714, themovement sensor 716, the electromyography sensor 717, the brain wavesensor 718, the energy field sensor 719, the body temperature sensor720, the analyte sensor 721, the pulse oximeter sensor 722, the bloodpressure sensor 723, and/or the electrodermal activity sensor 724. Inanother embodiment, the historical objective data 742 includesinformation gathered from the Maintenance of Wakefulness Test, the DigitSymbol Substitution Test, and/or the Psychomotor Vigilance Test. TheMaintenance of Wakefulness Test is described in Doghramji, et al., “Anormative study of the maintenance of wakefulness test (MWT)”,Electroencephalogr. Clin. Neurophysiol., 1997 November; 103(5): 554-562,which is incorporated herein by reference in its entirety. The DigitSymbol Substitution Test is described in Wechsler, D. (1997). WechslerAdult Intelligence Scale-Third edition (WAIS-III). San Antonio, Tex.:Psychological Corporation and Wechsler, D. (1997). Wechsler MemoryScale-Third edition (WMS-III). San Antonio, Tex.: PsychologicalCorporation, each of which is incorporated herein by reference in itsentirety. The Psychomotor Vigilance Test is described in Basner et al.,“Maximizing sensitivity of the psychomotor vigilance test (PVT) to sleeploss”, Sleep, 2011 May 1; 34(5): 581-91, which is incorporated herein byreference in its entirety.

The historical environmental data 744 includes information gathered fromthe environmental sensors 704. This includes information from theenvironmental temperature sensor 726, the humidity sensor 727, the noisesensor 728, the air quality sensor 730, the light sensor 732, and/or thebarometric sensor 734.

The historical subjective data 738 includes information regarding sleepand/or stress. In one embodiment, the information regarding sleep isgathered from manual sleep logs (e.g., Pittsburgh Sleep Quality Index).The manual sleep logs include, but are not limited to, a time sleep isfirst attempted, a time to fall asleep, a time of waking up, hours ofsleep, number of awakenings, times of awakenings, length of awakenings,perceived sleep quality, use of medications to assist with sleep,difficulty staying awake and/or concentrating during the day, difficultywith temperature regulation at night (e.g., too hot, too cold), troublebreathing at night (e.g., coughing, snoring), having bad dreams, wakingup in the middle of the night or before a desired wake up time,twitching or jerking in the legs while asleep, restlessness whileasleep, difficulty sleeping due to pain, and/or needing to use thebathroom in the middle of the night. The Pittsburgh Sleep Quality Indexis described in Buysse, et al., “The Pittsburgh sleep quality index: Anew instrument for psychiatric practice and research”. PsychiatryResearch. 28 (2): 193-213 (May 1989), which is incorporated herein byreference in its entirety.

In another embodiment, the historical subjective data 738 includesinformation gathered regarding sleepiness (e.g., Karolinska SleepinessScale, Stanford Sleepiness Scale, Epworth Sleepiness Scale). TheKarolinska Sleepiness Scale is described in Åkerstedt, et al.,“Subjective and objective sleepiness in the active individual”, Int JNeurosc., 1990; 52:29-37 and Baulk et al., “Driver sleepiness—evaluationof reaction time measurement as a secondary task”, Sleep, 2001;24(6):695-698, each of which is incorporated herein by reference in itsentirety. The Stanford Sleepiness Scale is described in Hoddes E.(1972). “The development and use of the Stanford sleepiness scale(SSS)”. Psychophysiology. 9 (150) and Maclean, et al. (1992 Mar. 1).“Psychometric evaluation of the Stanford Sleepiness Scale”. Journal ofSleep Research. 1 (1): 35-39, each of which is incorporated herein byreference in its entirety.

In yet another embodiment, the historical subjective data 738 includesinformation regarding tension or anxiety, depression or dejection, angeror hostility, and/or fatigue or inertia gathered from the Profile ofMood States. The Profile of Mood States is described in the Profile ofMood States, 2^(nd) Edition published by Multi-Health Systems (2012) andCurran et al., “Short Form of the Profile of Mood States (POMS-SF):Psychometric information”, Psychological Assessment. 7 (1): 80-83(1995), each of which is incorporated herein by reference in itsentirety. In another embodiment, the historical subjective data 738includes information gathered from the Ford Insomnia Response to StressTest (FIRST), which asks how likely a respondent is to have difficultysleeping in nine different situations. The FIRST is described in Drakeet al., “Vulnerability to stress-related sleep disturbance andhyperarousal”, Sleep, 2004; 27:285-91 and Drake et al., “Stress-relatedsleep disturbance and polysomnographic response to caffeine”, SleepMed., 2006; 7:567-72, each of which is incorporated herein by referencein its entirety. In still another embodiment, the historical subjectivedata 738 includes information gathered from the Impact of Events, whichassesses the psychological impact of stressful life events. A subscalescore is calculated for intrusion, avoidance, and/or hyperarousal. TheImpact of Events is described in Weiss, D. S., & Marmar, C. R. (1996).The Impact of Event Scale—Revised. In J. Wilson & T. M. Keane (Eds.),Assessing psychological trauma and PTSD (pp. 399-411). New York:Guilford, which is incorporated herein by reference in its entirety. Inone embodiment, the historical subjective data 738 includes informationgathered from the Social Readjustment Rating Scale (SRRS). The SRRSlists 52 stressful life events and assigns a point value based on howtraumatic the event was determined to be by a sample population. TheSRRS is described in Holmes et al., “The Social Readjustment RatingScale”, J. Psychosom. Res. 11(2): 213-8 (1967), which is incorporatedherein by reference in its entirety.

In one embodiment, the predefined programs 740 are general sleepsettings for various conditions and/or body types (e.g., weight loss,comfort, athletic recovery, hot flashes, bed sores, depression, multiplesclerosis, alternative sleep cycles). In one embodiment, a weight losspredefined program sets a surface temperature at a very cold setting(e.g., 15.56-18.89° C. (60-66° F.)) to increase a metabolic response,resulting in an increase in calories burned, which then leads to weightloss. Temperature settings are automatically adjusted to be as cold astolerable by the user after the first sleep cycle starts to maximize thecaloric burn while having the smallest impact on sleep quality. The coretemperature of an overweight individual may fail to drop due to a lowmetabolism. In one example, the surface temperature is 20° C. (68° F.)at the start of a sleep period, 18.89° C. (66° F.) during N1-N2 sleep,18.33° C. (65° F.) during N3 sleep, 19.44° C. (67° F.) during REM sleep,and 20° C. (68° F.) to wake the user.

In one embodiment, the custom programs 741 are sleep settings defined bythe user. In one example, the user creates a custom program by modifyinga predefined program (e.g., the weight loss program above) to be 1.11°C. (2° F.) cooler during the N3 stage. In another example, the usercreates a custom program by modifying a predefined program to have astart temperature of 37.78° C. (100° F.). The custom programs 741 allowa user to save preferred sleep settings.

The remote server 708 includes global historical subjective data 746,global historical objective data 748, global historical environmentaldata 750, global profile data 752, a global analytics engine 754, acalibration engine 756, a simulation engine 758, and a reasoning engine759. The global historical subjective data 746, the global historicalobjective data 748, the global historical environmental data 750, andthe global profile data 752 include data from multiple users.

The system components 710 include a mattress pad 11 with adjustabletemperature control, a mattress with adjustable firmness 768, a mattresswith adjustable elevation 770, an alarm clock 772, a thermostat toadjust the room temperature 774, a lighting system 776, a fan 778, ahumidifier 780, a dehumidifier 782, a pulsed electromagnetic field(PEMF) device 784, a transcutaneous electrical nerve stimulation (TENS)device 785, a sound generator 786, an air purifier 788, a scentgenerator 790, a red light and/or near-infrared lighting device 792, asunrise simulator 793, and/or a sunset simulator 794. In otherembodiments, the system components include a blanket, a pillow, a cap, ahead wrap, a vest, a sleeping bag, a cocoon, and/or a body wrap withadjustable temperature control. In yet another embodiment, temperatureis controlled with a mattress with temperature control (e.g.,temperature adjusted with a fluid, such as water or air). Althoughtemperature is described herein as being adjusted or controlled by amattress pad, it is equally likely that temperature is adjusted orcontrolled by the blanket, the pillow, the cap, the head wrap, the vest,the sleeping bag, the cocoon, the body wrap, and/or the mattress withtemperature control.

The body sensors 702, the environmental sensors 704, the remote device511 with local storage 706, the remote server 708, and the systemcomponents 710 are designed to connect directly (e.g., Universal SerialBus (USB) or equivalent) or wirelessly (e.g., Bluetooth®, Wi-Fi®,ZigBee®) through systems designed to exchange data between various datacollection sources. In a preferred embodiment, the body sensors 702, theenvironmental sensors 704, the remote device 511 with local storage 706,the remote server 708, and the system components 710 communicatewirelessly through Bluetooth®. Advantageously, Bluetooth® emits lowerelectromagnetic fields (EMFs) than Wi-Fi® and cellular signals.

Additional information regarding the stress reduction and sleeppromotion system in in U.S. Publication Nos. 20180000255 and 20180110960and U.S. application Ser. No. 16/686,394, filed Nov. 18, 2019, each ofwhich is incorporated herein by reference in its entirety. U.S.Application No. 62/792,572, filed Jan. 15, 2019, discusses a health dataexchange platform and is incorporated herein by reference in itsentirety.

In a preferred embodiment, the stress reduction and sleep promotionsystem 700 includes a mattress pad 11 to change the temperature of thesleep surface. FIG. 3 illustrates a thermoelectric control unit 10according to the present invention. As shown, a pair of identicalcontrol units 10, 10′ attach through flexible conduit to atemperature-conditioned article, such as mattress pad 11. The mattresspad 11 has two independent thermally regulated surface zones “A” and“B”, each containing internal flexible (e.g., silicon) tubing 14designed for circulating heated or cooled fluid within a hydrauliccircuit between the control unit 10 and the mattress pad 11. As bestshown in FIGS. 3 and 4, the flexible conduit assembly for each controlunit 10 includes separate fluid supply and return lines 16, 17 connectedto tubing 14, and a quick-release female connector 18 for readyattachment and detachment to external male connectors 19 of the controlunit 10. Advantageously, the mattress pad 11 allows a user to retrofitan existing mattress.

In one embodiment, the thermoelectric control unit 10 is operativelyconnected (e.g., by flexible conduit) to a mattress, such that thetemperature-conditioned surface is embedded in the mattress itself. Inalternative exemplary embodiments, the thermoelectric control unit 10 isoperatively connected (e.g., by flexible conduit) to any othertemperature regulated article, such as a blanket or other bedding orcovers, seat pad, sofa, chair, or the like.

As illustrated in FIGS. 5 and 6, the exemplary control unit 10 has anexternal housing 21, and a fluid reservoir 22 located inside the housing21. The reservoir 22 has a fill opening 23 accessible through aremovably capped opening 15 (FIG. 4) in housing 21, a fluid outlet 24,and a fluid return 25. Fluid contained in the reservoir 22 is moved in acircuit through a conduit assembly formed from in-housing tubes 28, theflexible supply and return lines 16, 17, and flexible silicone tubing 14within the temperature-regulated pad 11. The fluid is selectivelycooled, as described further below, by cooperating first and second heatexchangers 31, 32 and thermoelectric cooling modules 33A-33D. Thecooling modules 33A-33D reside at an electrified junction between thefirst and second heat exchangers 31, 32, and function to regulate fluidtemperature from a cool point of as low as 7.78° C. (46° F.), or cooler.The housing 21 and reservoir 22 may be either separately or integrallyconstructed of any suitable material, such as an anti-flammable ABS,polypropylene, or other molded polymer.

Referring to FIGS. 5 and 6, the first heat exchanger 31 is formed ofpairs of oppositely directed internal heat sinks 41A, 42A and 41B, 42Bcommunicating with an inside of the reservoir 22, and cooperating withthermoelectric cooling modules 33A-33D to cool the fluid inside thereservoir 22 to a selected (set) temperature. Each heat sink 41A, 42A,41B, 42B has a substantially planar metal base 44 adjacent an exteriorside wall of the reservoir 22, and a plurality of planar metal fins 45extending substantially perpendicular to the base 44 and verticallyinward towards a center region of the reservoir 22. In the exemplaryembodiment, each pair of heat sinks 41A, 42A and 41B, 42B is formed fromone 4-fin sink and one 5-fin sink arranged such that their respectivefins 45 are facing and interleaved as shown in FIG. 6. The exemplarycooling modules 33A-33D are operatively connected to an internal powersupply/main control board 48, and are formed from respective thinPeltier chips having opposing planar inside and outside major surfaces51, 52. The inside major surface 51 of each cooling module 33A-33Dresides in direct thermal contact with the planar base 44 of itscorresponding heat sink 41A, 42A, 41B, 42B. A thermal pad or compound(not shown) may also reside between each cooling module 33A-33D and heatsink 41A, 42A, 41B, 42B to promote thermal conduction from base 44outwardly across the fins 45.

The second heat exchanger 32 is formed from external heat sinks 61A-61Dlocated outside of the fluid reservoir 22, and arranged in anopposite-facing direction to respective internal heat sinks 41A, 42A,41B, 42B. Each external heat sink 61A-61D has a planar metal base 64 indirect thermal contact with the outside major surface 52 of anassociated adjacent cooling module 33A-33D, and a plurality of planarmetal fins 65 extending substantially perpendicular to the base 64 andhorizontally outward away from the fluid reservoir 22. Heat generated bythe cooling modules 33A-33D is conducted by the external heat sinks61A-61D away from the modules 33A-33D and dissipated to a surroundingenvironment outside of the fluid reservoir 22. Electric case fans 71 and72 may be operatively connected to the power supply/main control board48 and mounted inside the housing 21 adjacent respective heat sinks 61A,61B and 61C, 61D. The exemplary fans 71, 72 promote air flow across thesink fins 65, and outwardly from the control unit 10 through exhaustvents 13 formed with the sides and bottom of the housing 21. In oneembodiment, each external heat sink 61A-61D has a substantially largerbase 64 (as compared to the 4-fin and 5-fin internal sinks 41A, 42A,41B, 42B) and a substantially greater number of fins 65 (e.g., 32 ormore). Both internal and external heat sinks may be active or passive,and may be constructed of any suitable conductive material, includingaluminum, copper, and other metals. The heat sinks may have a thermalconductivity of 400 watts per meter-Kelvin (W/(m·K)), or more. The casefans 71, 72 may automatically activate and shut off as needed.

From the reservoir 22, the temperature conditioned fluid exits throughthe outlet 24 and enters the conduit assembly formed from an arrangementof in-housing Z-, L-, 7-, and S-shaped tubes 28 (and joints). A pump 81is operatively connected to the reservoir 22 and functions to circulatethe fluid through the control unit 10 in a circuit including thein-housing tubes 28 (and joints), flexible fluid supply line 16,silicone pad tubes 14, fluid return line 17, and back into the reservoir22 through fluid return 25. As shown in FIG. 5, an insulated linear heattube 82 is located outside of the fluid reservoir 22 and inside thehousing 21, and communicates with the conduit assembly to selectivelyheat fluid moving from the control unit 10 to the mattress pad 11. Theexemplary heat tube 82 may heat fluid moving in the hydraulic circuit toa desired temperature of as warm as 47.78° C. (118° F.).

The control unit has at least one fluid reservoir. In one embodiment,the control unit includes two fluid reservoirs. A first fluid reservoiris used to heat and/or cool fluid that circulates through thetemperature-regulated pad. The first fluid reservoir includes at leastone sensor to measure a level of the fluid. A second fluid reservoir isused to store fluid. In a preferred embodiment, fluid from the secondfluid reservoir is automatically used to fill the first fluid reservoirwhen the at least one sensor indicates that the level of the fluid isbelow a minimum value. Advantageously, this optimizes the temperature inthe first fluid reservoir because only a small amount of stored fluid isintroduced into the first fluid reservoir when needed. Additionally,this embodiment reduces the refilling required for the control unit,saving the user time and effort. In one embodiment, the at least onefluid reservoir is formed of metal. In another embodiment, the metal ofthe at least one fluid reservoir is electrically connected to ground.

In another embodiment, as shown in FIG. 41, the control unit 200includes at least one fluid reservoir 220 holding fluid to be circulatedthrough a temperature-regulated pad. The at least one fluid reservoir220 is positioned adjacent to at least one thermoelectric module 230containing at least one Peltier chip. In one embodiment, the at leastone thermoelectric module 230 contains four Peltier chips. Whenelectricity is provided to the at least one thermoelectric module 230,the at least one Peltier chip causes heating or cooling of the at leastone fluid reservoir 220. The at least one thermoelectric module 230 isconnected to a first heat sink 240 and a second heat sink 240 via atleast one heat tube 250. In one embodiment, the first heat sink 240 andthe second heat sink 240 are aligned along a common axis 255 with spaceseparating the first heat sink 240 from the second heat sink 240. The atleast one thermoelectric module 230 is positioned such that it is notaligned along the common axis 255 of the first heat sink 240 and thesecond heat sink 240 and such that the at least one thermoelectricmodule 230 is not located in the space between the first heat sink 240and the second heat sink 240. When the at least one thermoelectricmodule 230 is in cooling mode, the at least one heat tube 250 operatesto transfer heat away from the at least one thermoelectric module 230and toward the first heat sink 240 and the second heat sink 240. Thistransfer of heat increases the efficiency of the at least onethermoelectric module 230 and prevents the at least one thermoelectricmodule 230 from breaking down due to excessive heat buildup.

In one embodiment, the first heat sink 240 and the second heat sink 240each include a plurality of fins, with the fins assisting in dissipatingexcess heat. The plurality of fins each extend perpendicularly outwardfrom a base of each of the first heat sink 240 and second heat sink 240.In one embodiment, the first heat sink 240 is connected to at least onefirst fan 270 and the second heat sink 240 is connected to at least onesecond fan 270. When active, the at least one first fan 270 blows airover the first heat sink 240 in a first direction and the at least onesecond fan 270 sucks air from the second heat sink 240 in the firstdirection, thereby creating a common air path 275 along the common axis255 between the first heat sink 240 and the second heat sink 240. Thecommon air path 275 increases the efficiency of the first heat sink 240and the second heat sink 240. Additionally, because the at least onethermoelectric module 230 is positioned such that it is not alignedalong the common axis 255 of the first heat sink 240 and the second heatsink 240, and is therefore not in the common air path 275, airpossessing residual heat from the first heat sink 240 and the secondheat sink 240 is not blown directly over the at least one thermoelectricmodule 230. Furthermore, in one embodiment, the control unit 200includes a partition 245, separating the common air path 275 from the atleast one fluid reservoir 220. Including the partition 245 helps toensure that the temperature of the at least one fluid reservoir 220 isnot directly affected by the temperature of the air, which woulddecrease the thermal efficiency of the device.

In one embodiment, the thermoelectric module includes at least one firstPeltier chip that is separated from at least one second Peltier chip.The at least one first Peltier chip heats and/or cools fluid travelingto a first location, while the at least one second Peltier chip heatsand/or cools fluid traveling to a second location, such that the atleast one first Peltier chip is part of an independent thermalregulation loop than the at least one second Peltier chip. Separatingthe at least one first Peltier chip and the at least one second Peltierchip allows the control unit 200 to regulate two different articles atdifferent temperatures.

As shown in FIGS. 42 and 43, in one embodiment, the first heat sink 240and the second heat sink 240 are connected by a chassis 280, which actsas an electromagnetic field (EMF) shield. In one embodiment, the chassis280 is a strip having approximately the same thickness as the first heatsink 240 and second heat sink 240. In another embodiment, the chassis280 substantially surrounds the interior of the control unit. In yetanother embodiment, the chassis 280 covers only one side of the controlunit, such as the side that would typically be placed closer to a bed.In one embodiment, the chassis 280 is formed from one or more sheetmetals, such as copper, aluminum, cobalt, brass, nickel, silver, steel,tin, or other metals able to act as a shield to EMF radiation. Inanother embodiment, the chassis 280 is formed from a metal foam or froma conductive non-metal fabric capable of stopping EMF radiation, such asnylon coated or interwoven with a conductive metal material.

EMF radiation has been shown, in some cases, to increase the quantity ofmelatonin produced during sleep, which can cause a poorer quality ofsleep. In addition, individuals have been shown to experience symptomsincluding headaches, nausea, and fatigue when exposed to EMF radiation,especially over longer periods of time. Therefore, the inclusion of thechassis 280 in the control unit helps prevent prolonged exposure tousers of EMF radiation produced by the control unit's operation, whichmay otherwise disrupt their sleep or cause other adverse symptoms.

FIG. 44 shows a section view of a control unit according to oneembodiment of the present invention. A partition 330 extends from oneend of the at least one fan 312 to a back end of the control unit 300,dividing the control unit into two separate sections. The at least onefan 312 and the at least one heat sink 310 are positioned in a firstsection of the control unit, on one side of the partition 330. The atleast one thermoelectric module 320, the at least one fluid reservoir306, and at least one fluid outlet tube 322 are positioned in a secondsection of the control unit, on the other side of the partition 330. Theplurality of heat tubes 314 extend from the at least one heat sink 310to the at least one thermoelectric module 320. The partition 330 ensuresthat the air path generated by the at least one fan 312 is substantiallyisolated from the at least one thermoelectric module 320 and the rest ofa water heating and cooling path located on the opposite side of thepartition 330. By isolating the air path from the water heating andcooling path, the thermal efficiency of the thermoelectric module 320 isincreased, as the temperature of the air does not directly interferewith the heating or cooling provided by the at least one thermoelectricmodule 320.

In one embodiment, the control unit includes at least one pump connectedto the at least one fluid reservoir 306. The at least one pump isoperable to increase or decrease the flow of fluid out of the at leastone fluid reservoir 306 to the at least one thermoelectric module 320.Including at least one pump helps the control unit to control the flowof fluid even if the control unit is turned on its side. By contrast,gravity-assisted systems are often unable to achieve sufficient fluidflow if they are tilted relative to the ground, resulting in a lessrobust system. Furthermore, because gravity-assisted systems require afluid reservoir to be placed at a high point and other components of thesystem to be placed at a point lower than the fluid reservoir, suchsystems often require more space vertically. Therefore, it is a benefitof the present system that it is able to maintain a relatively lowerprofile compared to gravity-assisted systems. Maintaining a relativelylower profile helps the control unit to more easily fit under a bed foreasy storage and use. Accordingly, the present invention does notinclude a gravity-assisted system in one embodiment.

The fluid circulation system is separated from the at least one fan 312and the at least one heat sink 310 by the partition 330, as shown inFIGS. 45 and 46. The partition 330 further houses a power supply unit334, which generates and supplies energy to the control unit. Becausethe power supply unit 334 is located on the same side of the controlunit as the at least one fan 312, the at least one fan 312 providescooling for the components of the power supply unit 334, which otherwiseheat during operation of the control unit. The at least one fan 312 isoperable to generate an air path over the at least one heat sink 310.However, the partition 330 prevents the air path from intersecting withthe at least one fluid reservoir and the at least one thermoelectricmodule. Furthermore, in one embodiment, the air path intersect with thepower supply unit 334, such that the air path cools the power supplyunit 334.

FIG. 46 is an isometric section view of a control unit for aclimate-control system according to one embodiment of the presentinvention. For ease of visualization, the at least one fluid reservoirhas been removed from the view shown in FIG. 46. The at least one fluidreservoir is attached to and positioned on top of at least one fluidreservoir stand 332. The at least one fluid reservoir stand 332 includesat least one tube connecting the fluid within the at least one fluidreservoir to the rest of the fluid circulation system in the controlunit. After fluid exits the at least one fluid reservoir, it enters intoa first pump 340, which pushes the fluid into an accumulator 342. Fluidis extracted from the accumulator 342 by a second pump 344, which pushesthe fluid through a plurality of tubes 346 entering, exiting, andreentering the at least one thermoelectric module 320. In anotherembodiment, fluid is extracted from the at least one fluid reservoir byat least one pump and directly moved to the at least one thermoelectricmodule, without first passing through an accumulator.

After passing through the at least one thermoelectric module 320, thefluid exits the control unit through at least one fluid outlet tube 322.Although not visible in FIG. 46, fluid reenters the control unit throughat least one fluid inlet tube, which is connected to the second pump344. The second pump 344 then pushes the fluid back through the at leastone thermoelectric module 320, allowing the fluid to be again cooled orheated before reexiting the control unit. By having the reentering fluidnever return to the at least one fluid reservoir, new fluid from the atleast one fluid reservoir is able to be entirely separated fromreentering fluid. This is useful, as it allows the fluid in the at leastone fluid reservoir to be replaced less frequently, as the fluid in theat least one fluid reservoir will always be entirely unused.

In one embodiment, the accumulator 342 is also attached to a third pump.Fluid that is extracted and pushed by the third pump enters, exits, andreenters the at least one thermoelectric module 320 through an entirelyindependent and separate plurality of tubes than the plurality of tubes346 connected to the second pump 344. Furthermore, fluid extracted bythe third pump exits the control unit through a second outlet tube,which is independent and separate from the at least one fluid outlettube 322. After the fluid enters and exits at least one article, itreenters the control unit through a second inlet tube, which isindependent and separate from the at least one inlet tube, and thenreenters the third pump.

In a preferred embodiment, the control unit includes at least onemechanism for forming structured water. FIG. 7 illustrates thedifference between structured water and unstructured water. In oneembodiment, the control unit includes at least one vortex to treat thefluid. The at least one vortex reduces bacteria, algae, and fungus inthe fluid without using additional chemicals. In one embodiment, the atleast one vortex includes at least one left spin vortex and at least oneright spin vortex. The at least one left spin vortex and the at leastone right spin vortex mimics the movement of water in nature. Oneexample of utilizing vortex technologies to treat fluids is described inU.S. Pat. No. 7,238,289, which is incorporated herein by reference inits entirety. Alternatively, the fluid flows or tumbles over or througha series of balls and/or rocks. In one embodiment, the rocks are in ahexagonal shape. A tumbling action or vortex aligns the molecules in thestructured water to retain energy (i.e., cooling or heating) for alonger period of time. Surprisingly, the aligned or structured watermolecules produce a 20% increase in the heating and cooling capacity ofthe water.

In a preferred embodiment, the fluid is water. In one embodiment, thewater is treated with an ultraviolet (UV) purification system to killmicroorganisms (e.g., bacteria, viruses, molds). The UV purificationsystem includes at least one UV light bulb to expose microorganisms toUV radiation, which prevents the microorganisms from reproducing. Thisreduces the number of microorganisms in the water without usingadditional chemicals. In one embodiment, the at least one UV light bulbis a UV-C light emitting diode (LED). In another embodiment, the atleast one UV light bulb is a mercury vapor bulb.

Additionally or alternatively, the water is treated with at least onefilter to remove contaminants and/or particles. In a preferredembodiment, the at least one filter clarifies the water before exposureto the at least one UV light bulb. Contaminants and/or particles in thewater are larger than the microorganisms, so contaminants and/orparticles block the UV rays from reaching the microorganisms. In oneembodiment, the at least one filter is a sediment filter, an activatedcarbon filter, a reverse osmosis filter, and/or a ceramic filter. Inanother embodiment, one or more of the at least one filter includescopper and/or silver (e.g., nanoparticles, ions, colloidal) to suppressthe growth of microorganisms. Contaminants and/or particles that areremoved from the water include sediment, rust, calcium carbonate,organic compounds, chlorine, and/or minerals.

The at least one filter preferably removes contaminants and/or particleswith a diameter greater than 0.3 μm. Alternatively, the at least onefilter removes contaminants and/or particles with a diameter greaterthan 0.5 μm. In another embodiment, the at least one filter removescontaminants and/or particles with a diameter greater than 0.05 μm. Inanother embodiment, the at least one filter removes contaminants and/orparticles with a diameter greater than 1 nm.

In one embodiment, the water is treated with copper and/or silver ions.The copper and/or silver ions are positively charged and bond withnegative sites on cell walls of microorganisms. This can lead to thedeactivation of proteins and ultimately to cell death. Copper and/orsilver ions can also destroy biofilms and slimes. In one embodiment, thecopper and/or silver ions are created through electrolysis.

Alternatively, the water is treated with at least one chemical toinhibit growth of bacteria and microorganisms or to remove lime andcalcium buildup. In one embodiment, the water is treated with a compoundcontaining iodine or chlorine. In another embodiment, the water istreated with salt and/or a peroxide solution. In yet another embodiment,the water is treated with citric acid.

The thermoelectric control unit may further include other features andelectronics not shown. In one embodiment, the control unit includes atouch control and display board, overheat protectors, fluid levelsensor, thermostat, additional case fans, and/or at least one speaker.The control unit may also include an external power cord designed toplug into standard household electrical outlets, or may be powered usingrechargeable or non-rechargeable batteries. In one embodiment, the touchcontrol and display board includes a power button, temperature selectionbuttons (e.g., up arrow and down arrow), and/or an LCD to display thetemperature. In another embodiment, the touch control and display boardincludes a program selection menu.

The control unit preferably has at least one processor. By way ofexample, and not limitation, the processor may be a general-purposemicroprocessor (e.g., a central processing unit (CPU)), a graphicsprocessing unit (GPU), a microcontroller, a Digital Signal Processor(DSP), an Application Specific Integrated Circuit (ASIC), a FieldProgrammable Gate Array (FPGA), a Programmable Logic Device (PLD), acontroller, a state machine, gated or transistor logic, discretehardware components, or any other suitable entity or combinationsthereof that can perform calculations, process instructions forexecution, and/or other manipulations of information. In one embodiment,one or more of the at least one processor is operable to run predefinedprograms stored in at least one memory of the control unit.

The control unit preferably includes at least one antenna, which allowsthe control unit to receive and process input data (e.g., temperaturesettings, start and stop commands) from at least one remote device(e.g., smartphone, tablet, laptop computer, desktop computer, remotecontrol). In a preferred embodiment, the at least one remote device isin wireless network communication with the control unit. The wirelesscommunication is, by way of example and not limitation, radiofrequency,Bluetooth®, ZigBee®, Wi-Fi®, wireless local area networking, near fieldcommunication (NFC), or other similar commercially utilized standards.Alternatively, the at least one remote device is in wired communicationwith the control unit through USB or equivalent.

In a preferred embodiment, the at least one remote device is operable toset target temperatures for the mattress pad. The at least one remotedevice preferably has a user interface (e.g., a mobile application for asmartphone or tablet, buttons on a remote control) that allows a user toselect target temperatures for the mattress pad or independent zoneswithin the mattress pad. In one embodiment, the mattress pad includestemperature probes in each zone that provide temperature data for thatzone to the at least one processor, which compares a target temperatureset using the at least one device to an actual measured temperature todetermine whether to heat or cool the fluid and determine where todistribute the heated or cooled fluid in order to make the actualtemperature match the target temperature.

Those skilled in the art will recognize that programmatic control of thetarget temperatures over time, such as over the course of a night'ssleep, is possible using the at least one remote device. Because thetarget temperatures can be set at any time, those target temperaturescan be manipulated through the sleeping period in order to match userpreferences or a program to correlate with user sleep cycles to producea deeper, more restful sleep.

FIG. 8A illustrates one embodiment of a mattress pad with threeindependent temperature zones. The three independent temperature zones501, 502, 503 generally correspond to the head, body and legs, and feet,respectfully, of a user. Although only three zones are shown, it isequally possible to have one, two, four, or more independent temperaturezones. A wireless remote control 507 is used to set the targettemperatures for each of the zones 501, 502, 503. Fluid is delivered tothe mattress pad 11 from the control unit 10 via a fluid supply line 16that enters the continuous perimeter via an opening sized to sealinglyreceive the fluid supply line 16. Fluid is removed from the mattress pad11 and returned to the control unit 10 via a fluid return line 17 thatexits the continuous perimeter via an opening sized to sealingly receivethe fluid return line 17.

Temperature probes 508 in each zone provide actual measured temperaturedata for that zone to the control unit 10. The control unit 10 comparesthe target temperature set using the wireless remote control 507 and theactual measured temperature to determine whether to heat or cool thefluid and determine to which conduit or circuits the heated or cooledfluid should be distributed in order to make the actual temperaturematch the target temperature.

In one embodiment, a larger number of temperature probes are in theindependent temperature zones corresponding to the core body region, anda smaller number of temperature probes are in the independenttemperature zones not corresponding to the core body region. In oneexample, zone 501 contains three temperature probes, zone 502 containsfive temperature probes, and zone 503 contains three temperature probes.This embodiment provides the advantage of more closely monitoring thetemperature of the pad in the core body region, which is importantbecause core body temperature impacts how well a user sleeps.

In another embodiment, an independent temperature zone contains threetemperature probes. In one example, zone 501 contains a temperatureprobe in the center of the mattress pad 11, a temperature probe on theleft side of the mattress pad 11, and a temperature probe on the rightside of the mattress pad 11. Advantageously, this embodiment providesinformation about the left, center, and right of the mattress pad. Inyet another embodiment, an independent temperature zone contains atleast three temperature probes.

The mattress pad includes padding 509 between the conduit circuits andthe resting surface, in order to improve the comfort of a user and toprevent the concentrated heat or cold of the conduit circuits from beingapplied directly or semi-directly to the user's body. Instead, theconduit circuits heat or cool the padding 509, which provides moregentle temperature modulation for the user's body.

FIG. 8B illustrates one embodiment of a double mattress pad. Threeindependent temperature zones 501A, 502A, 503A generally correspond tothe head, body and legs, and feet, respectfully, of a first user whoutilizes surface zone “A”. Three independent temperature zones 501B,502B, 503B generally correspond to the head, body and legs, and feet,respectfully, of a second user who utilizes surface zone “B”. Althoughonly three zones are shown for each user, it is equally possible to haveone, two, four, or more independent temperature zones. A first wirelessremote control 507A is used to set the target temperatures for each ofthe zones 501A, 502A, 503A. A second wireless remote control 507B isused to set the target temperatures for each of the zones 501B, 502B,503B. Temperature probes 508 in each zone provide actual measuredtemperature data for that zone to the control unit 10. The control unit10 compares the target temperature set using the wireless remote control507A, 507B and the actual measured temperature to determine whether toheat or cool the fluid and determine to which conduit or circuits theheated or cooled fluid should be distributed in order to make the actualtemperature match the target temperature.

In this embodiment, despite the presence of two separate controls, asingle control unit 10 is utilized to control the temperature of thefluid. In another embodiment, a first control unit is utilized tocontrol the temperature of the fluid for the first user and a secondcontrol unit is utilized to control the temperature of the fluid for thesecond user. Alternatively, each user has at least two control units tocontrol the temperature of the fluid.

FIG. 8C illustrates one embodiment of a mattress pad with threeindependent temperature zones connected to at least one remote device511. In a preferred embodiment, the at least one remote device is asmartphone or a tablet. The at least one remote device preferably has amobile application that allows for the control unit 10 to vary thetemperature of the mattress pad 11 according to a schedule of targettemperatures selected to correlate with sleep cycles of the user. Suchan arrangement promotes deeper, more restful sleep by altering bodytemperature at critical points.

Preferably, the mattress pad is sized to fit standard mattress sizes.For example, twin (about 97 cm by about 191 cm (about 38 inches by about75 inches)), twin XL (about 97 cm by about 203 cm (about 38 inches byabout 80 inches)), full (about 137 cm by about 191 cm (about 54 inchesby about 75 inches)), queen (about 152 cm by about 203 cm (about 60inches by about 80 inches)), king (about 193 cm by about 203 cm (about76 inches by about 80 inches), and California king (about 183 cm byabout 213 cm (about 72 inches by about 84 inches)). In one embodiment,the mattress pad is about 76 cm by about 203 cm (about 30 inches byabout 80 inches). This allows a single user of a full, queen, or kingsize bed to use the mattress pad without affecting a sleeping partner.In one embodiment, the mattress pad is sized to fit a crib mattress(about 71 cm by about 132 cm (about 28 inches by about 52 inches)). In apreferred embodiment, the single mattress pad (e.g., twin, twin XL,sized to fit a single user of a larger bed, crib) attaches to onecontrol unit and the double mattress pad (e.g., full, queen, king,California king) attaches to two control units.

In an alternative embodiment, the mattress pad contains a conductivefiber to heat one section of the mattress pad and water circulation tocool another section of the mattress pad. In one example, this allowsthe temperature of the main body or body core region to be lower thanthe temperature for the feet. The feet play an active role in theregulation of body temperature. The feet have a large surface area andspecialized blood vessels, which allow the feet to release heat from thebody. If the feet become too cold, excess heat cannot be released fromthe body and an individual will not be able to sleep.

In one embodiment, the mattress pad is grounded, which provides thehuman body with electrically conductive contact with the surface of theearth. Grounding is based on the theory that the earth is a source ofnegatively charged free electrons, and, when in contact with the earth,the body can use these free electrons as antioxidants to neutralize freeradicals within the body. Grounding the body during sleep can normalizecortisol levels, improve sleep, and decrease pain and stress levels. Ina preferred embodiment, the mattress pad has a conductive material on atleast one exterior surface of the mattress pad. In one embodiment, themattress pad is attached to a wire that is electrically connected to anelectrical outlet ground port. Alternatively, the mattress pad isattached to a wire that is connected to a ground rod.

The mattress pad includes at least two layers of a waterproof materialthat are laminated, affixed to each other, adhered to each other,attached to each other, secured to each other, or welded together toprevent separation or delamination of the layers. In a preferredembodiment, the waterproof material is a urethane or a mixture ofurethane and ethylene-vinyl acetate (EVA). A first layer of thewaterproof material is permanently affixed to a second layer of thewaterproof material. The first layer of the waterproof material has anexterior surface and an interior surface. The second layer of thewaterproof material has an exterior surface and an interior surface. Ina preferred embodiment, the first layer of the waterproof material iswelded (e.g., using high frequency/radio frequency (RF) welding or heatwelding) to the second layer of the waterproof material along acontinuous perimeter, creating at least one interior chamber constructedand configured to retain fluid without leaking between the interiorsurface of the first layer of the waterproof material and the interiorsurface of the second layer of the waterproof material. Fluid isdelivered to the at least one interior chamber via a fluid supply linethat enters the continuous perimeter via an opening sized to sealinglyreceive the fluid supply line. Fluid is removed from the at least oneinterior chamber via a fluid return line that exits the continuousperimeter via an opening sized to sealingly receive the fluid returnline.

In a preferred embodiment, the waterproof material is covered on theexterior surfaces with an interlock or knit fabric. The interlock orknit fabric on the exterior surface of the mattress pad preferablycontains a copper or a silver ion thread for antimicrobial protection.Alternatively, the interlock or knit fabric on the exterior surface ofthe mattress pad is treated with an antibacterial or an antimicrobialagent (e.g., Microban®). In one embodiment, the waterproof material iscovered on the exterior surface with a moisture wicking material.

In one embodiment, the mattress pad includes a spacer layer positionedwithin the interior chamber between the interior surface of the firstlayer of the waterproof material and the interior surface of the secondlayer of the waterproof material. The spacer layer provides separationbetween the first layer of the waterproof material and the second layerof the waterproof material, ensuring that the fluid flows through themattress pad when a body is on the mattress pad. The spacer layeradvantageously provides structural support to maintain partial channelsthrough the interior chamber or fluid passageways, which are importantto ensure constant and consistent fluid flow through the interiorchamber with heavy users on firm mattresses. In a preferred embodiment,the spacer layer is laminated, affixed, adhered, attached, secured, orwelded to the first layer of the waterproof material and/or the secondlayer of the waterproof material. The spacer layer is preferably made ofa foam mesh or a spacer fabric. In one embodiment, the spacer layer hasantimicrobial properties.

FIG. 9A illustrates a cross-section of a mattress pad with two layers ofwaterproof material. In this embodiment, a first layer of a waterproofmaterial 602 and a second layer of a waterproof material 604 are affixedor adhered together to form an interior chamber 600. The interiorchamber 600 is constructed and configured to retain fluid withoutleaking. In a preferred embodiment, the first layer of the waterproofmaterial 602 and the second layer of the waterproof material 604 arewelded together (e.g., using high frequency/radio frequency (RF) weldingor heat welding).

FIG. 9B illustrates a cross-section of a mattress pad with two layers ofwaterproof material and two layers of a second material. In thisembodiment, a first layer of a waterproof material 602 and a secondlayer of a waterproof material 604 are affixed or adhered together toform an interior chamber 600. The interior chamber 600 is constructedand configured to retain fluid without leaking. In a preferredembodiment, the first layer of the waterproof material 602 and thesecond layer of the waterproof material 604 are welded together (e.g.,using high frequency/radio frequency (RF) welding or heat welding). Afirst layer of a second material 606 is on an exterior surface of thefirst layer of the waterproof material 602. A second layer of the secondmaterial 608 is on an exterior surface of the second layer of thewaterproof material 604. In a preferred embodiment, the second materialis a knit or interlock material. Alternatively, the second material is awoven or non-woven material. In yet another embodiment, the secondmaterial is formed of plastic.

FIG. 9C illustrates a cross-section of a mattress pad with two layers ofwaterproof material and a spacer layer. In this embodiment, a firstlayer of a waterproof material 602 and a second layer of a waterproofmaterial 604 are affixed or adhered together to form an interior chamber600. The interior chamber 600 is constructed and configured to retainfluid without leaking. In a preferred embodiment, the first layer of thewaterproof material 602 and the second layer of the waterproof material604 are welded together (e.g., using high frequency/radio frequency (RF)welding or heat welding).

A spacer layer 610 is positioned within the interior chamber 600 betweenan interior surface of the first layer of the waterproof material 602and an interior facing of the second layer of the waterproof material604. The spacer layer 610 is configured to provide structural support tomaintain partial channels for fluid flow through the interior chamber.In one embodiment, the fluid flows through the spacer layer. In apreferred embodiment, the spacer layer is laminated, affixed, adhered,attached, secured, or welded to the first layer of the waterproofmaterial and/or the second layer of the waterproof material. The spacerlayer is preferably made of a foam mesh or a spacer fabric. In oneembodiment, the spacer layer has antimicrobial properties. In anotherembodiment, the spacer layer 610 is in a honeycomb shape.

FIG. 9D illustrates a cross-section of a mattress pad with two layers ofwaterproof material, two layers of a second material, and a spacerlayer. In this embodiment, a first layer of a waterproof material 602and a second layer of a waterproof material 604 are affixed or adheredtogether to form an interior chamber 600. The interior chamber 600 isconstructed and configured to retain fluid without leaking. In apreferred embodiment, the first layer of the waterproof material 602 andthe second layer of the waterproof material 604 are welded together(e.g., using high frequency/radio frequency (RF) welding or heatwelding). A first layer of a second material 606 is on an exteriorsurface of the first layer of the waterproof material 602. A secondlayer of the second material 608 is on an exterior surface of the secondlayer of the waterproof material 604. In a preferred embodiment, thesecond material is a knit or interlock material. Alternatively, thesecond material is a woven or non-woven material. In yet anotherembodiment, the second material is formed of plastic.

A spacer layer 610 is positioned within the interior chamber 600 betweenan interior surface of the first layer of the waterproof material 602and an interior facing of the second layer of the waterproof material604. The spacer layer 610 is configured to provide structural support tomaintain partial channels for fluid flow through the interior chamber.In one embodiment, the fluid flows through the spacer layer. In apreferred embodiment, the spacer layer is laminated, affixed, adhered,attached, secured, or welded to the first layer of the waterproofmaterial and/or the second layer of the waterproof material. The spacerlayer is preferably made of a foam mesh or a spacer fabric. In oneembodiment, the spacer layer has antimicrobial properties.

As previously described, the mattress pad includes two layers of awaterproof material and at least one additional layer of a secondmaterial in one embodiment. Although FIGS. 9B and 9D illustrate a firstlayer of the second material 606 and a second layer of the secondmaterial 608, in one embodiment, the first layer of the second material606 is present without the second layer of the second material 608.Alternatively, the second layer of the second material 608 is presentwithout the first layer of the second material 606.

In another embodiment, the mattress pad includes at least one layer of athermally reflective and/or an insulating material (e.g., lyocell, suchas TENCEL). In one embodiment, the first layer of the second material606 and/or the second layer of the second material 608 is a thermallyreflective and/or the insulating material. In another embodiment, thethermally reflective and/or the insulating material is positionedbetween the second layer of the waterproof material 604 and the secondlayer of the second material 608. In yet another embodiment, thethermally reflective and/or the insulating material is positionedbetween the first layer of the waterproof material 602 and the firstlayer of the second material 606.

In one embodiment, the mattress pad absorbs heat from the mattress.Advantageously, providing the thermally reflective and/or the insulatingmaterial between the waterproof layer of the mattress pad and themattress reduces the thermal demand on the cooling unit withoutimpacting the rate of heat transfer from the occupant.

FIG. 10 is a view of a mattress pad hose elbow according to a preferredembodiment. The mattress pad 11 is placed on top of a mattress 102 andbox springs or foundation 104. The mattress pad 11 connects to thecontrol unit (not shown) via a flexible hose 106 containing the flexiblesupply and return lines. The flexible hose is preferably formed from apolyurethane. Alternatively, the flexible hose is formed from extrudedsilicone double wall tubing. In one embodiment, the flexible hose has apolyethylene foam or other insulating cover. Additionally oralternatively, the flexible hose is covered with a fabric (e.g., nylon,polyester, rayon).

A mattress pad hose elbow 108 is concentric around the flexible hose106. The mattress pad hose elbow 108 secures the flexible hose 106 tothe side of the mattress 102 and box springs or foundation 104, whichprovides structural support to the flexible hose 106. The mattress padhose elbow 108 is sized to fit tightly around the flexible hose 106. Ina preferred embodiment, the mattress pad hose elbow 108 is formed withsilicone or rubber. Alternatively, the mattress pad hose elbow 108 isformed from plastic (e.g., ethylene-vinyl acetate (EVA) foam,polyethylene foam). In a preferred embodiment, the mattress pad hoseelbow 108 is operable to slide on the flexible hose 106. In oneembodiment, the mattress pad hose elbow 108 is adjustable.

The mattress pad 11 preferably contains a plurality of holes or openings100 in the surface of the mattress pad 11. The plurality of holes oropenings 100 direct the movement of the fluid in the pad. In a preferredembodiment, the plurality of holes or openings 100 is in a pre-selectedpattern to help manufacturing efficiency. Alternatively, the pluralityof holes or openings 100 is in a random pattern. The plurality of holesor openings 100 is shown in a hexagon shape in FIG. 10. Alternatively,the shape of each of the plurality of holes or openings 100 can be inthe shape of a triangle, a circle, a rectangle, a square, an oval, adiamond, a pentagon, a heptagon, an octagon, a nonagon, a decagon, atrapezium, a parallelogram, a rhombus, a cross, a semicircle, acrescent, a heart, a star, a snowflake, or any other polygon. In oneembodiment, the voids created by the plurality of holes or openings 100include at least 80% of the surface area of the mattress pad. In otherembodiments, the voids created by the plurality of holes or openings 100include at least 5%, at least 10%, at least 15%, at least 20%, at least25%, at least 30%, at least 40%, at least 50%, at least 60%, at least70%, at least 75%, at least 85%, at least 90%, or at least 95% of thesurface area of the mattress pad.

The spacing and number of the plurality of holes or openings 100 can bevaried to adjust the thermal properties of the mattress pad. Forexample, in one embodiment, the density of the holes or openings ishigher near the torso region than in the head and leg regions, forproviding more exposure to the torso region of the user for managingbody temperature in that region, and less exposure to the extremities ofthe user. In one embodiment, the spacing between each of the pluralityof holes or openings is at least 5 mm (0.2 inches).

Alternatively, the mattress pad includes a first layer having aplurality of shapes and a second layer having a corresponding pluralityof shapes. The second layer is permanently affixed to the first layeralong a periphery of the article and a periphery of each of the shapes.This embodiment differs from the one shown including the plurality ofholes and openings in that the first layer and the second layer do notcontain holes. However, this embodiment is functionally equivalent tothe one with the plurality of holes and openings because the fluid doesnot travel through the shapes.

In a preferred embodiment, the mattress pad 11 contains at least oneweld line 105 to help manage the flow of the fluid in the interiorchamber. The at least one weld line 105 preferably directs the fluidflow through the pad from head to foot, and returns the fluid to thecontrol unit via the return line. The at least one weld line 105 allowsthe fluid to flow across all areas of the mattress pad 11 to provide asubstantially uniform temperature within the pad. In one embodiment, theat least one weld line is formed from the permanent attachment of thefirst layer of the waterproof material and the second layer of thewaterproof layer along the periphery of the plurality of holes oropenings.

FIG. 11 is another view of the mattress pad hose elbow of FIG. 10. Theflexible hose 106 is positioned next to the mattress 102 and the boxsprings or foundation 104 using the mattress pad hose elbow 108.Advantageously, the mattress pad hose elbow 108 secures the flexiblehose 106 to the side of the mattress 102 and box springs or foundation104, providing structural support for the flexible hose 106. Further,the total height of a mattress, box springs or foundation, and/or a bedframe is not uniform. The mattress pad hose elbow 108 providescustomization for the height of the mattress, the box springs orfoundation, and/or the bed frame.

In another embodiment, the flexible hose is positioned next to themattress using hook and loop tape. In yet another embodiment, theflexible hose is positioned next to the mattress using elastic. In stillanother embodiment, the flexible hose is positioned next to the mattressusing at least one snap. Alternatively, the flexible hose is positionednext to the mattress using at least one buckle.

FIG. 12 is a top perspective view of a single mattress pad. A top panel110A is attached (e.g., sewn, adhered, welded) to the top of themattress pad 11 at an attachment point 114A. A bottom panel 110B isattached (e.g., sewn, adhered, welded) to the bottom of the mattress pad11 at an attachment point 114B. A non-slip piece 112A is attached (e.g.,sewn, adhered, welded) to the top panel 110A on a side opposite theattachment point 114A. A non-slip piece 112B is attached (e.g., sewn,adhered, welded) to the bottom panel 110B on a side opposite theattachment point 114B. Preferably, the top panel 110A and the bottompanel 110B are formed from the same material as the second material(e.g., a knit or interlock fabric) on the exterior surface of themattress pad. In a preferred embodiment, the non-slip pieces 112A, 112Bare formed from foam. Alternatively, the non-slip pieces 112A, 112B areformed from latex, silicon, or rubber. The non-slip pieces 112A, 112Bare preferably moisture wicking and/or antimicrobial. In one embodiment,the non-slip pieces 112A, 112B are printed onto the top panel 110A andthe bottom panel 110B. In one embodiment, the top panel 110A and thebottom panel 110B are between about 18 cm (about 7 inches) and about 76cm (about 30 inches) in length. In a preferred embodiment, top panel110A and the bottom panel 110B are about 66 cm (about 26 inches) inlength.

In another embodiment, the top panel 110A and the bottom panel 110B actas a non-slip surface. In one embodiment, the top panel 110A and thebottom panel 110B are made of gripper or anti-slip fabric. In thisembodiment, the non-slip pieces 112A and 112B are not needed because thetop panel 110A and the bottom panel 110B act as the non-slip surface.

The single mattress pad is preferably reversible, such that the mattresspad is operable when either exposed surface is facing upward.Advantageously, this allows the flexible hose to exit on either the leftor the right side of the bed. This reversibility eliminates the need tomanufacture single mattress pads with a “left” configuration or a“right” configuration for single users of a full, queen, or king sizebed and/or single users where a bed is positioned such that a particularconfiguration is required (e.g., a bed positioned against a wall).

FIG. 13 is an exploded view of a single mattress pad. The mattress pad11 is shown above the mattress 102 and the box springs or foundation104. While in use, the mattress pad 11 is placed on top of the mattress102. The ends of the mattress pad 11 are attached to panels 110A, 110B.Panels 110A, 110B are placed over the head and foot ends of the mattress102, with the ends of the panels 110A, 110B sandwiched between themattress 102 and box springs or foundation 104.

As previously described, the mattress pad 11 preferably contains aplurality of holes or openings 100 in the surface of the mattress pad11. A first layer having a plurality of holes or openings is permanentlyaffixed to a second layer having a plurality of holes or openings alonga periphery of the mattress pad and a periphery of each of the pluralityof holes or openings. At least one interior chamber is defined betweenan interior surface of the first layer and an interior surface of thesecond layer. The at least one interior chamber is constructed andconfigured to retain a fluid without leaking. The interior surface ofthe first layer and the interior surface of the second layer are made ofat least one layer of a waterproof material.

In an alternative embodiment, the mattress pad does not contain aplurality of holes or openings in the surface in the mattress pad. Afirst layer is permanently affixed to a second layer along a peripheryof the mattress pad. In one embodiment, the waterproof material isstretchable. In a preferred embodiment, the stretch rate of thewaterproof material is equal to or greater than the stretch rate ofsurrounding materials (e.g., a mattress). Advantageously, this preventsthe mattress pad from gathering and bunching underneath a user.

FIG. 14 is an exploded view of an end of a single mattress pad. Themattress pad 11 is formed of at least two layers of waterproof materialas shown in FIGS. 9A-9D. In one embodiment, the panel 110 is permanentlyaffixed (e.g., sewn, adhered, welded) between a first layer of awaterproof material 602 and a second layer of a waterproof material 604.On the opposite end from where the panel 110 is attached to the mattresspad 11, a non-slip piece 112 is permanently affixed (e.g., sewn,adhered, welded) to the panel. In a preferred embodiment, the non-slippiece 112 is formed from foam. Alternatively, the non-slip pieces 112are formed from latex, silicon, or rubber. The non-slip pieces 112 arepreferably moisture wicking and/or antimicrobial.

FIG. 15 is a side perspective view of an end of a single mattress pad.The mattress pad 11 has a first layer of waterproof material 602 and asecond layer of waterproof material 604. A first end of panel 110 isattached to the first layer of waterproof material 602 and the secondlayer of waterproof material 604. The panel 110 is permanently affixed(e.g., sewn, adhered, welded) between the first layer of waterproofmaterial 602 and the second layer of waterproof material 604. In apreferred embodiment, the external surface of the first layer ofwaterproof material 602 and the second layer of waterproof material 604are folded over to attach to the first end of panel 110. A non-slippiece 112 is permanently affixed (e.g., sewn, adhered, welded) to theend opposite of the first end of panel 110. In a preferred embodiment,the non-slip piece 112 is formed from foam. Alternatively, the non-slippieces 112 are formed from latex, silicon, or rubber. The non-slippieces 112 are preferably moisture wicking and/or antimicrobial.

In alternative embodiments, the mattress pad includes interlock or knitfabric on exterior surfaces of the mattress pad. In other embodiments,the exterior surfaces of the mattress pad are covered with a wovenfabric, a non-woven fabric, or a polymer film (e.g., urethane orthermoplastic polyurethane (TPU)). Additionally or alternatively, themattress pad includes a spacer layer between an interior surface of thefirst layer of waterproof material 602 and an interior surface of thesecond layer of waterproof material 604.

FIG. 16 is a top perspective view of a double mattress pad. The mattresspad 11 has two independent thermally regulated surface zones “A” and“B”. The mattress pad 11 has a first flexible hose 106A and a secondflexible hose 106B. In a preferred embodiment, the first flexible hose106A attaches to a first control unit (not shown) and the secondflexible hose 106B attaches to a second control unit (not shown). In apreferred embodiment, the center of the mattress pad 11 contains an areafree of holes or openings 124. The area free of holes or openings 124contains a welded separator 126, which provides a boundary between thetwo independent thermally regulated surface zones “A” and “B”.

FIG. 17 is another top perspective view of a double mattress pad. Themattress pad 11 has a top end panel 110A, a left side panel 110B, aright side panel 110C, and a bottom end panel 110D. The top end panel110A, the left side panel 110B, the right side panel 110C, and thebottom end panel 110D are preferably formed from a material with stretch(e.g., interlock or knit). In a preferred embodiment, each corner of themattress pad 11 contains at least one non-slip piece. In one embodiment,a top non-slip piece and a bottom non-slip piece are attached to eachcorner of the mattress pad 11. In the embodiment shown in FIG. 17, thecorner between the top end panel 110A and the left side panel 110B has anon-slip piece 130A, the corner between the top end panel 110A and theright side panel 110C has a non-slip piece 130B, the corner between theleft side panel 110B and the bottom end panel 110D has a non-slip piece130C, and the corner between the right side panel 110C and the bottomend panel 110D has a non-slip piece 130D.

The mattress pad 11 preferably contains at least one weld line or otherseparation to help manage the flow of fluid in the at least one interiorchamber. The at least one weld line 105 directs the fluid flow throughthe pad from head to foot, and returns the fluid to the control unit viathe return line. In FIG. 17, the mattress pad has a first weld line 105Ato help manage the flow of fluid in the interior chamber of zone “A” anda second weld line 105B to help manage the flow of fluid in the interiorchamber of zone “B”. Although only one weld line is shown for eachindependent temperature zone, it is equally possible to have two or moreweld lines for each independent temperature zone.

FIG. 18 is an exploded view of a double mattress pad. The mattress pad11 is shown above the mattress 102 and the box springs or foundation104. The mattress pad 11 has a first flexible hose 106A and a secondflexible hose 106B. In a preferred embodiment, the first flexible hose106A attaches to a first control unit (not shown) and the secondflexible hose 106B attaches to a second control unit (not shown).Alternatively, the first flexible hose 106A and the second flexible hose106B attach to the same control unit. The surface of the mattress pad 11contains a plurality of holes or openings 100 in the surface of themattress pad 11.

FIG. 19 is an exploded view of the bottom left corner of one embodimentof a double mattress pad before the mattress pad is secured to the bed.In a preferred embodiment, each corner of the mattress pad 11 contains atop non-slip piece 130C and a bottom non-slip piece 130C′. In FIG. 19,the top non-slip piece 130C and the bottom non-slip piece 130C′ areshown attached (e.g., sewn, adhered, welded) to the corner formedbetween the left side panel 110B and the bottom end panel 110D. The leftside panel 110B and the bottom end panel 110D are preferably formed froma material with stretch (e.g., interlock or knit). In one embodiment,elastic is attached (e.g., sewn, adhered, welded) to a bottom edge ofthe left side panel 110B and a bottom edge of the bottom end panel 110D.Alternatively, elastic is encased at the bottom edge of the left sidepanel 110B and the bottom edge of the bottom end panel 110D.

To secure the mattress pad 11 to the bed, the edge of the left sidepanel 110B and the edge of the bottom panel 110D are placed on top ofthe bottom non-slip piece 130C′. The top non-slip piece 130C is thenplaced on top the left side panel 110B, bottom panel 110D, and thebottom non-slip piece 130C′. The top non-slip piece 130C and bottomnon-slip piece 130C′ are preferably formed from non-slip foam.Alternatively, the top non-slip piece 130C and bottom non-slip piece130C′ are formed from silicone, rubber, or latex. In one embodiment, theleft side panel 110B and the bottom panel 110D are formed from amaterial with stretch (e.g., interlock or knit). The top non-slip piece130C and bottom non-slip piece 130C′ provide friction to keep themattress pad in place.

FIG. 20 is a view of the bottom left corner of a double mattress padafter the mattress pad is secured to the bed.

FIG. 21 is a view of another embodiment of the mattress pad. Theplurality of holes or openings 100 is shown in a circle shape in FIG.21. The voids created by the plurality of holes or openings 100 includeat least 80% of the surface area of the mattress pad 11 in thisembodiment.

In one embodiment, the control unit is operable to drop a temperature ofwater from 68° F. to 58° F. in less than 5.3 minutes when in a closedloop (i.e., without the mattress pad attached). In one embodiment, theclosed loop consists of 14″ long silicone tubing with an outer diameterof ⅜″, an inner diameter of ¼″, and ⅜″ 90° circular plastic connector.The mattress pad preferably has a rate of heat transfer of at least 200W at a water temperature of 14.4° C. (58° F.). In another embodiment,the mattress pad has a rate of heat transfer of at least 150 W at awater temperature of 14.4° C. (58° F.).

FIG. 22 illustrates a total heat transfer rate vs. bulk watertemperature for a hydro layer mattress pad without any additional layersof material (e.g., FIG. 9A), a tubing mattress pad (e.g., FIG. 3), ahydro layer mattress pad with a layer of TENCEL between the pad and themattress (e.g., FIG. 9B), a hydro layer mattress pad with an additionallayer of waterproof material, such as polyester with urethane laminate(e.g., FIG. 9B). As can be seen in FIG. 22, the layer of TENCEL betweenthe pad and the mattress significantly decreases the heat transfer rate.

FIG. 23 illustrates a human heat transfer rate vs. bulk watertemperature for a hydro layer mattress pad without any additional layersof material (e.g., FIG. 9A), a tubing mattress pad (e.g., FIG. 3), ahydro layer mattress pad with a layer of TENCEL between the pad and themattress (e.g., FIG. 9B), a hydro layer mattress pad with an additionallayer of waterproof material, such as polyester with urethane laminate(e.g., FIG. 9B). As can be seen in FIG. 23, the layer of TENCEL betweenthe pad and the mattress reduces the thermal demand without impactingthe rate of heat transfer from the user.

In an alternative embodiment, the mattress pad includes tubing (e.g.,FIG. 3) with a layer of insulating fabric (e.g., TENCEL) positionedbetween the tubing and the mattress.

FIG. 24 illustrates a comparison between several differentthermoelectric cooler (TEC) configurations. The graph shows coolingpower vs. power consumption. TEC 1 has 127 couples and a maximumamperage of 6 A. TEC2 has 161 couples and a maximum amperage of 9 A. Thegraph compares multiple configurations, including two 127 couple, 6 ATECs (2×TEC1); two 161 couple, 9 A TECs (2×TEC2); three 127 couple, 6 ATECs (3×TEC1); three 161 couple, 9 A TECs (3×TEC2); two cooling unitseach containing two 127 couple, 6 A TECs (2 cooling units X 2×TEC1);four 161 couple, 9 A TECs (4×TEC); double heatsinks and two 127 couple,6 A TECs (double heatsink 2×TEC1); and two cooling units each containingtwo 161 couple couple, 9 A TECs (2 cooling units X 2×TEC2). As can beseen by the graph, efficiency degrades as the maximum cooling capacityis approached.

FIG. 25 is three-dimensional graph showing the total thermoelectriccooler (TEC) capacity vs. the heat sink thermal resistance vs. themaximum system cooling power for two 127 couple, 6 A TECs (2×TEC1); two161 couple, 9 A TECs (2×TEC2); and four 161 couple, 9 A TECs (4×TEC2).TEC capacity and heat sink capacity are increased together for bestpower increase.

As shown in FIG. 26, in one embodiment, the remote server 708 hosts aglobal analytics engine 754, a calibration engine 756, a simulationengine 758, a reasoning engine 759, and databases 796, 797, 798, and799. Although four databases are shown, it is equally possible to haveany number of databases greater than one. The global analytics engine754 generates predicted values for a monitored stress reduction andsleep promotion system using a virtual model of the stress reduction andsleep promotion system based on real-time data. The calibration engine756 modifies and updates the virtual model based on the real-time data.Any operational parameter of the virtual model may be modified by thecalibration engine 756 as long as the resulting modification is operableto be processed by the virtual model.

The global analytics engine 754 analyzes differences between thepredicted values and optimized values. If the difference between theoptimized values and the predicted values is greater than a threshold,then the simulation engine 758 determines optimized values of themonitored stress reduction and sleep promotion system based on thereal-time data and user preferences. In one embodiment, the globalanalytics engine 754 determines whether a change in parameters of thesystem components 710 is necessary to optimize sleep based on the outputof the simulation engine 758. If a change in parameters is necessary,the new parameters are transmitted to a mobile application on the remotedevice and then to the system components 710. The calibration engine 756then updates the virtual model with the new parameters. Thus, the systemautonomously optimizes the stress reduction and sleep promotion system(e.g., surface temperature) without requiring input from a user.

In another embodiment, the remote server 708 includes a reasoning engine759 built with artificial intelligence (AI) algorithms. The reasoningengine 759 is operable to generate a reasoning model based on multiplesets of training data. The multiple sets of training data are a subsetof global historical subjective data, global historical objective data,global historical environmental data, and global profile data. Forexample, a user's stress level and/or sleep efficiency significantlyimprove after engaging in an activity over a period of time, which isthen included in the training data. The training data includes contextdata (e.g., baseline data, body sensor data) and action data (e.g.,activity data, system component use). The reasoning model is updatedperiodically when there is an anomaly indicated in the action dataproduced by the reasoning data based on the context data. Each of U.S.Pat. No. 9,922,286 titled “Detecting and Correcting Anomalies inComputer-Based Reasoning Systems” and U.S. application Ser. No.15/900,398 is incorporated herein by reference in its entirety.

FIG. 27 is an illustration of a network of stress reduction and sleeppromotion systems. Data from multiple users can be stored on a remoteserver 708. The remote server 708 is connected through a network andcloud computing system to a plurality of remote devices 511. Each of theplurality of remote devices 511 is connected to body sensors 702 and/orenvironmental sensors 704, as well as system components 710. Althoughone remote server is shown, it is equally possible to have any number ofremote servers greater than one. A user may opt into sending their datato the remote server 708, which is stored in at least one database onthe remote server 708. The simulation engine on the remote server 708 isoperable to use data from the multiple users to determine customized andoptimized sleep settings for the user based on personal preferences(e.g., a target number of hours of sleep, a preferred bed time, apreferred wake time, a faster time to fall asleep, fewer awakeningsduring the sleeping period, more REM sleep, more deep sleep, and/or ahigher sleep efficiency) or physical condition (e.g., weight loss,comfort, athletic recovery, hot flashes, bed sores, depression). In oneexample, the temperature settings for a temperature-conditioned mattresspad for a user with hot flashes are automatically determined by thesimulation engine examining data obtained from other users with hotflashes and a temperature-conditioned mattress pad stored in databaseson the remote server. The simulation engine is also operable to use datafrom the multiple users to provide recommendations (e.g., activities,system components) to users with a similar background (e.g., gender,age, health condition).

The stress reduction and sleep promotion system includes a virtual modelof the stress reduction and sleep promotion system. The virtual model isinitialized based on the program selected. The virtual model of thestress reduction and sleep promotion system is dynamic, changing toreflect the status of the stress reduction and sleep promotion system inreal time or near-real time. The virtual model includes information fromthe body sensors and the environmental sensors. Based on the data fromthe body sensors and the environmental sensors, the virtual modelgenerates predicted values for the stress reduction and sleep promotionsystem. A sleep stage (e.g., awake, Stage N1, Stage N2, Stage N3, REMsleep) for the user is determined from the data from the body sensors.

The stress reduction and sleep promotion system is monitored todetermine if there is a change in status of the body sensors (e.g.,change in body temperature), the environmental sensors (e.g., change inroom temperature), the system components (e.g., change in temperature ofmattress pad), or sleep stage of the user. If there is a change instatus, the virtual model is updated to reflect the change in status.Predicted values are generated for the stress reduction and sleeppromotion system. If a difference between the optimized values and thepredicted values is greater than a threshold, a simulation is run on thesimulation engine to optimize the stress reduction and sleep promotionsystem based on the real-time data. The simulation engine usesinformation including, but not limited to, global historical subjectivedata, global historical objective data, global historical environmentaldata, and/or global profile data to determine if a change in parametersis necessary to optimize the stress reduction and sleep promotionsystem. In one example, the temperature of the mattress pad is loweredto keep a user in Stage N3 sleep for a longer period of time. In anotherexample, the mobile application provides recommendations of an activityto a user.

FIG. 28 is a diagram illustrating an example process for monitoring astress reduction and sleep promotion system and updating a virtual modelbased on monitored data. First, in step 2202, a program to control thestress reduction and sleep promotion system is loaded onto a remotedevice. In a preferred embodiment, the program is a predefined programor customized program based on user preferences. Optimized valuesincluding, but not limited to, the sleep status, parameters for systemcomponents, and/or times for changes, from the program are loaded ontothe global analytics engine in step 2204. Real-time data is received bythe remote server via the remote device in step 2206. The real-time datais used to monitor the status of the stress reduction and sleeppromotion system in step 2208. As described above, the stress reductionand sleep promotion system includes body sensors, environmental sensors,a remote device with local storage, a remote server, and systemcomponents. Accordingly, the status of the body sensors, theenvironmental sensors, and the system components are monitored in step2208, as well as the sleep status of a user. In step 2210, adetermination is made regarding whether there is a change in the statusof the monitored devices and/or the sleep state. If there is a change,then the virtual model is updated in step 2212 by the calibration engineto reflect the status change, i.e., the corresponding virtual componentsdata is updated to reflect the actual status of the various monitoreddevices.

In step 2214, predicted values for the monitored stress reduction andsleep promotion system are generated based on the current, real-timestatus of the monitored system. In one embodiment, the predicted valuesinclude, but are not limited to, sleep stage (e.g., awake, Stage N1,Stage N2, Stage N3, REM Sleep). In step 2216, the optimized valuesloaded in step 2204 are compared with the predicted values obtained instep 2214.

Accordingly, meaningful predicted values based on the actual conditionof monitored stress reduction and sleep promotion system are generatedin step 2214. These predicted values are then used to determine iffurther action should be taken based on the results of the comparison instep 2216. For example, if it is determined in step 2218 that thedifference between the predicted values and the optimized values is lessthan or equal to a threshold, then a do not calibrate instruction isissued in step 2220. If the difference between the real-time data andthe predicted values is greater than the threshold, as determined instep 2218, then an initiate simulation command is generated in step2222.

In step 2224, a function call to the simulation engine is generated inresponse to the initiate simulation command. The simulation engineselects optimized values for the stress reduction and sleep promotionsystem in step 2226. These optimized values are updated on the globalanalytics engine in step 2204. Based on the output of the simulationengine, the global analytics engine determines if the optimized valuesrequire a change in parameters of the stress reduction and sleeppromotion system (e.g., temperature of mattress pad, room temperature,lighting, mattress firmness, mattress elevation) in step 2228. In apreferred embodiment, the simulation engine uses the global historicalsubjective data, the global historical objective data, the globalhistorical environmental data, and the global profile data to determineif the change in parameters is necessary. If a change in parameters isnot necessary, a do not calibrate instruction is issued in step 2230. Ifa change in parameters is necessary, the new parameters are transmittedto the remote device in step 2232. The remote device transmits the newparameters to the system components in step 2234.

The calibration engine updates the virtual model in step 2212 based onthe real-time data and the new parameters. Predicted values are thengenerated in step 2214. In this manner, the predicted values generatedin step 2214 are not only updated to reflect the actual status ofmonitored stress reduction and sleep promotion system, but they are alsoupdated to reflect natural changes in monitored system as the user movesthrough the sleep cycle. Accordingly, realistic predicted values can begenerated in step 2214.

As previously mentioned, the at least one remote device preferably has auser interface (e.g., a mobile application for a smartphone or tablet)that allows the stress reduction and sleep promotion system to adjustthe parameters of the stress reduction and sleep promotion system. Theparameters of the stress reduction and sleep promotion system (e.g.,target temperatures of a mattress pad) can be manipulated through thesleeping period using a predefined program or a customized program basedon user preferences to produce a deeper, more restful sleep.

Because the target temperatures may be set at any time, those targettemperatures may be manipulated through the sleeping period in order tomatch user preferences or a program to correlate with user sleep cyclesto produce a deeper, more restful sleep.

In one embodiment, the mobile application measures a time when a userbegan attempting to sleep (TATS), a TATS start time, a TATS end time, atime in bed (TIB), a TIB start time, and/or a TIB end time. The mobileapplication calculates a total TATS duration based on the TATS starttime and the TATS end time. The mobile application also calculates atotal TIB duration based on the TIB start time and the TIB end time. Inone embodiment, the TATS start time, the TATS end time, the TIB starttime, and/or the TIB end time are indicated by the user (e.g., bypressing a button in the mobile application). Alternatively, the TATSstart time, the TATS end time, the TIB start time, and/or the TIB endtime are determined by sensors. In one example, the TATS start time isdetermined by a user's eyes closing while in bed. In another example,the TATS end time is determined by increased motion as measured by amovement sensor and/or opening of the eyes. In yet another example, theTIB start time is determined by sensors indicating a user is horizontaland/or bed or room sensors indicating the user is in bed. In stillanother example, the TIB end time is determined by sensors indicating auser is not horizontal and/or bed or room sensors indicating the user isnot in bed.

The mobile application is operable to determine whether a user is awakeor asleep. The state of wakefulness (i.e., “awake”) is characterized bycognitive awareness and/or consciousness, responsiveness toenvironmental cues, sustained movement detected by a movement sensor,beta and/or alpha waves as detected by EEG, increased heart rate,increased respiration, increased blood pressure, increased electrodermalactivity, increased body temperature, open eyes, voluntary eyemovements, and/or increased EMG on the chin. The state of sleep (i.e.,“asleep”) is characterized by loss of alertness and/or consciousness,lack of response to environmental cues, lack of movement, reduction inalpha waves as detected by EEG, increased theta and delta waves asdetected by EEG, decreased heart rate, decreased respiration, decreasedblood pressure, decreased body temperature, closed eyes, eye twitches,and/or decreased oxygen saturation.

In a preferred embodiment, the mobile application is operable to measurean initial sleep onset time and/or a final awakening time. The initialsleep onset time is a first occurrence of sleep after the TATS starttime. The final awakening time is a time immediately after the lastoccurrence of sleep before the TATS end time. In one embodiment, themobile application calculates a latency to sleep onset as the durationof a time interval between the TATS start time to the initial sleeponset time. In another embodiment, the mobile application calculates alatency to arising as the duration of a time interval between the finalawakening time to the TATS end time. In a preferred embodiment, themobile application is operable to calculate a sleep efficiencypercentage. In one embodiment, the sleep efficiency percentage isdefined as the total sleep time divided by the total TATS duration. Inan alternative embodiment, the sleep efficiency percentage is defined asthe total sleep time divided by the total TIB duration.

In one embodiment, the mobile application is operable to determine atotal sleep period duration, a total sleep time, a sleep maintenancepercentage, a total wakefulness duration, a wakefulness duration afterinitial sleep onset, a total number of awakenings, an awakening rate perhour, and/or a sleep fragmentation rate.

In another embodiment, the mobile application is operable to determineREM sleep, N1 sleep, N2 sleep, and/or N3 sleep. REM sleep ischaracterized by low-voltage, mixed-frequency EEG activity with lessthan 15 seconds of alpha activity, saw-tooth theta EEG activity, rapideye movements, and/or decreased or absent EMG activity on the chin. N1sleep is characterized by low-voltage, mixed-frequency EEG activity withless than 15 seconds of alpha activity in a 30-second epoch, no sleepspindles or K complexes, possible slow rolling eye movements, and/ordiminished EMG activity on the chin. N2 sleep is characterized by sleepspindle and/or K complex activity, absence of eye movements, and/ordiminished EMG activity on the chin. N3 sleep is characterized by highamplitude (e.g., greater than 75 μV peak-to-peak), slow wave (e.g.,frequency of 4 Hz or less) EEG activity. In yet another embodiment, themobile application is operable to calculate REM sleep duration,percentage, and latency from sleep onset; N1 sleep duration, percentage,and latency from sleep onset; N2 sleep duration, percentage, and latencyfrom sleep onset; and/or N3 sleep duration, percentage, and latency fromsleep onset.

Alternatively, the calculations and determining of sleep statesdescribed above are determined over the network on a remote server. Inone embodiment, the calculations and determining of sleep states arethen transmitted to at least one remote device. In yet anotherembodiment, the calculations and determining of sleep states describedabove are determined using third party software and transmitted to themobile application.

The mobile application preferably serves as a hub to interface with thesystem components, the body sensors, the environmental sensors, and/orat least one third-party application (e.g., Apple® Health,MyFitnessPal®, nutrition tracker). The mobile application is operable toobtain data from a mattress pad (e.g., OOLER) and/or a wearable (e.g.,OURA, Apple Watch®, Fitbit®).

Sleep Density vs. Sleep Efficiency

There are numerous sleep tracking algorithms. However, generally manysleep tracking algorithms focus on sleep efficiency. Sleep efficiency isbased on total time sleeping versus time in bed. Therefore, the focusbecomes on sleep latency, wake-ups, and time spent sleeping in anoptimal sleep window rather than whether a user feels recovered and wellrested.

In contrast, deep sleep or slow wave sleep (SWS) is the most effectiveway for an average user to feel recovered from sleep. As a result, thepresent invention is directed to increasing a total time and/or apercentage of time in deep sleep. In one embodiment, a sleep density isdefined as the percentage of time in deep sleep. To increase the totaltime and/or the percentage of time in deep sleep, a core bodytemperature of the user is cooled within a window of non-shiveringthermogenesis.

One of the unfortunate effects of aging is that less time is spent indeep sleep. Healthy people in their 20s spend about 20% of a sleepingperiod in Stage 3, while a typical 40- or 50-year-old spends about 10%of a sleeping period in Stage 3. By age 70 or 80, an average of about 5%of a sleeping period is spent in Stage 3, and sometimes about 2%. Oneway to approximate an age of an individual is to measure an amount ofStage 3 sleep (e.g., using EEG).

FIG. 29 is an average deep sleep percentage by age. In one embodiment,the stress reduction and sleep promotion system includes a targetpercentage of deep sleep by age. An example of target percentages ofdeep sleep by age is shown in FIG. 30. In another embodiment, the targetpercentage of deep sleep by age is equal to the average deep percentageby age. In yet another embodiment, the target percentage of deep sleepfor an obese person is equal to the average deep sleep percentage by ageof the next highest age group. For example, the target deep sleep of a36-year old obese user is equal to the average deep sleep percentage byage of 46-55-year-old users (e.g., 12-16%).

Temperature Regulation

As previously described, humans are homeothermic and require a nearlyconstant internal body temperature for maintaining normal physiologicalfunctions. Body temperature increases during exercise and fever, andvaries with temperature extremes of the surrounding environment. Thehomeostatic mechanisms for regulating body temperature represent thethermoregulatory system. Body temperature is controlled by balancingheat production against heat loss.

As shown in PRIOR ART FIG. 31, the body is divided into a warm internalcore and a cooler outer shell. The internal body temperature is thetemperature of the vital organs inside the head and trunk, which,together with a variable amount of other tissue, comprise the warminternal core. The temperature of the internal core of the body remainsvery constant, within ±1.1° C. (2° F.). The temperature of the outershell is strongly influenced by the environment, and is not regulatedwithin narrow limits like the internal body temperature. Thethermoregulatory responses strongly affect the temperature of the shell,especially its outermost layer, the skin. Heat is transferred within thebody both from the core to the skin and from major sites of heatproduction to the rest of the body. The shell lies between the core andthe environment. All heat leaving the body core, except heat lostthrough the respiratory tract, must pass through the shell before beinglost to the environment. Thus, the shell insulates the core from theenvironment.

Heat production is a principal by-product of metabolism. The rate ofheat production (i.e., metabolic rate) is determined by factorsincluding, but not limited to, basal metabolic rate of all the cells ofthe body, muscle activity, hormones (e.g., thyroxine, growth hormone,testosterone, epinephrine, norepinephrine), sympathetic stimulation onthe cells, and/or metabolism needed for digestion, absorption, andstorage of food.

Heat is transported within the body by two means: conduction through thetissues and convection by the blood. Heat flow by conduction variesdirectly with the thermal conductivity of the tissues. Heat flow byconvection depends on the rate of blood flow, which is controlled by thedegree of vasoconstriction of the arterioles and the arteriovenousanastomoses that supply blood to the skin. This vasoconstriction iscontrolled almost entirely by the sympathetic nervous system in responseto changes in core body temperature and changes in environmentaltemperature.

PRIOR ART FIG. 32 illustrates heat loss of the body. Heat loss occursthrough a variety of mechanisms, including radiation (e.g., infraredheat rays), conduction, convection, evaporation, and respiration. Whenthe body temperature is greater than the environmental temperature, alarger quantity of heat is radiated from the body than is radiated tothe body. Conduction to air accounts for approximately 15% and directconduction from the body surface to solid objects accounts forapproximately 3%. Convection is the removal of heat from the body byconvection air currents. Evaporation is heat loss from the body viasweat. Respiration accounts for approximately 10% of heat loss.

Temperature Changes Using Cold Therapy

As previously described, cold therapy can be used to treat insomniaand/or provide more restful sleep. The core body temperature naturallydecreases by 0.56-1.1° C. (1-2° F.) during a sleep period as shown inPRIOR ART FIG. 33.

Deep sleep is Stage 3 sleep, which shows up on an EEG as delta waves. Itis more difficult to wake up people in deep sleep than light sleep.Additionally, sleep inertia results from being woken up during deepsleep. Further, individuals in deep sleep are less likely to waken inresponse to external stimuli than those in light sleep. As previouslystated, deep sleep is the most refreshing sleep, as subjectivelydescribed by individuals after waking up. However, aging results in lessdeep sleep.

Deep sleep provides many benefits. The pituitary gland secretes humangrowth hormone in the first deep sleep episode of the night. Deep sleepis also associated with repairing and regrowing tissues, building boneand muscle, and strengthening the immune system. If an individual doesnot get enough deep sleep to feel refreshed and is allowed to sleep foran extra amount of time the following night, almost of all of the misseddeep sleep is recovered, while the amount of REM and light sleep arelower.

By decreasing a temperature of the mattress pad following sleep onset,it is possible to increase an amount of deep sleep. In a preferredembodiment, a total time and/or a percentage of time in deep sleep isincreased by decreasing the temperature of the mattress pad. In oneembodiment, an amount of deep sleep in a first sleep cycle is increasedby decreasing the temperature of the mattress pad. The temperature ofthe mattress pad is cooler in the first half of the sleeping period andwarmer in the second half of the sleeping period. Advantageously, thiskeeps the user cool to thermally neutral as the user progresses in thecircadian rhythm to the second half of the sleeping period where theuser's core body temperature increases. In a last quarter of thesleeping period, the mattress pad maintains thermal neutrality, whichallows the user to maintain sleep and permits REM-heavy sleep cycles.Humans are in the thermal neutral zone (i.e., thermally neutral) whenthe rate of heat production equals the rate of heat loss to theenvironment. The thermal neutral zone is shown in PRIOR ART FIG. 34.

Chronic insomniacs and commuters who chronically sleep 6 hours or lessare able to improve to 2 hours of deep sleep without increasing thetotal time spent sleeping. Using temperature modified sleep (e.g.,cooling), improvements in deep sleep, heart rate variability, andresting heart rate are possible without adding additional sleep time.This is improved sleep density. The amount of light sleep becomesshorter, with only a small change in the amount of REM sleep.

Non-Shivering Thermogenesis

Non-shivering thermogenesis increases metabolic heat production withoutproducing mechanical work. Skeletal muscle and brown adipose tissue(BAT) are the major sources of heat produced by non-shiveringthermogenesis in adults. The metabolic rate of skeletal muscle and BATis controlled by norepinephrine released from adrenergic nerve terminalsand is further mediated locally by an uncoupling protein, UCP-1.Additional information regarding non-shivering thermogenesis is found inCannon, Barbara, and Jan Nedergaard. “Nonshivering thermogenesis and itsadequate measurement in metabolic studies.” Journal of ExperimentalBiology 214.2 (2011): 242-253, which is incorporated herein by referencein its entirety. Benefits of non-shivering thermogenesis includeincreased fat loss, less inflammation, increased lifespan, strengthenednervous system, increased healing and recovery, regulated blood sugarlevels, improved sleep quality, strengthened immune system, enhanceddetoxification, reduced pain, and increased bone health.

Heart Rate

Heart rate (i.e., pulse) is dependent on many factors including, but notlimited to, age, health, gender, and fitness level. Generally, a lowerresting heart rate indicates a higher level of cardiovascular health,while a higher resting heart rate indicates a higher risk of cardiacevents (e.g., stroke, heart attack). PRIOR ART FIG. 35 includes a tableof resting heart rates for men and women with a rating (i.e., athletes,excellent, good, above average, average, below average, and poor) fordifferent age groups. Therefore, a high resting heart rate is anindicator of a lack of activity, overtraining, mental stress, emotionalstress, sleep deprivation, dehydration, and/or development of a medicalcondition (e.g., Type 2 diabetes). Further, medications can impactresting heart rate. For example, medications that treat asthma,attention deficit disorder, depression, and obesity may increase restingheart rate, while medications that treat hypertension and heartconditions (e.g., beta blockers, calcium channel blockers) may decreaseresting heart rate. Additionally, resting heart rate may indicate animpending illness. For example, resting heart rate will generallyincrease a few days before the onset of flu systems.

Heart rate varies throughout the day. An optimal heart rate curve duringsleep is a hammock-shaped curve as shown in PRIOR ART FIG. 36. The bodyrelaxes and blood pressure and heart rate drop during the first sleepcycles. Heart rate is lowest during the middle of a sleep period whenthe amount of melatonin is highest. Heart rate then increases inpreparation to wake.

Heart Rate Variability

Heart rate variability is dependent on many factors including, but notlimited to, age, health, gender, and fitness level. PRIOR ART FIG. 37 isa graph of HRV normal values vs. age and sex. HRV, like deep sleep,declines with age. This decline in HRV indicates decreasedparasympathetic activation with respect to age. Higher HRV is correlatedwith increased fitness and health, while lower HRV indicates a higherbiological age. As seen in PRIOR ART FIG. 37, gender differences in HRVdecrease after the age of 55 years, due to age-related hormone effectsin women (i.e., menopause). In a preferred embodiment, HRV is based on aroom mean square of the successive differences (RMSSD). Alternatively,HRV is based on a standard deviation of NN intervals (SDNN), a standarddeviation of RR intervals (SDRR), a number of pairs of successive NNintervals that differ by more than 50 ms (NN50), a proportion of NN50divided by a total number of NN intervals, a natural log of the RMSSD(ln(RMSSD)), or a ratio of low frequency to high frequency power(LF/HF). Low frequency power is measured in a frequency band of0.04-0.15 Hz. High frequency power is measured in a frequency band of0.15-0.4 Hz.

In one embodiment, a normalized LF value and a normalized HF value areutilized to determine a balance between the sympathetic nervous systemand the parasympathetic nervous system. The normalized LF value and thenormalized HF value are expressed as a percentage of the sum of LF andHF (e.g., normalized HF=HF/(LF+HF)). Ideally, the normalized LF valueand the normalized HF value are equal, which indicates optimal bodyfunction. If the ratio is larger than 0.75:0.25 (e.g., 0.8:0.2) orsmaller than 0.25:0.75 (e.g., 0.2:0.8), this is an indication ofinadequate recovery, high stress, chronic stress, fatigue, and/ormalfunction within the body.

Heart rate variability is also an indication of recovery during a sleepperiod. An HRV value at sleep onset (e.g., night) shows stressaccumulated during a waking period (e.g., day). An HRV value at waking(e.g., morning) shows recovery status (e.g., during night) and readinessfor activity during the waking period (e.g., day). Therefore, HRV can beused to optimize a training and/or an exercise schedule. A high HRV atthe start of a sleeping period corresponds to a stressful or heavytraining day, while a low HRV at the start of a sleeping periodcorresponds to an easy or light training day. A high HRV at wakingcorresponds to a good recovery during the sleeping period, while a lowHRV at waking corresponds to an incomplete recovery during the sleepingperiod.

In one embodiment, RMSSD is used to determine recovery during a sleepingperiod. In another embodiment, HRV is measured in intervals (e.g.,3-minute intervals) throughout the sleeping period. In yet anotherembodiment, a linear fit of RMSSD is completed for HRV values obtainedthroughout the sleeping period. A positive slope of the linear fit ofRMSSD indicates a good recovery, a slope of about 0 of the linear fit ofRMSSD indicates an easy or light training day with little need forrecovery, and a negative slope of the linear fit of RMSSD indicates astressful or heavy training day with incomplete recovery. In stillanother embodiment, at least one historical RMSSD value is compared toan RMSSD value during a most recent sleeping period. For example, the atleast one historical RMSSD value is an average RMSSD value and/or ahistogram obtained over a period of time (e.g., over a 7-day period,over a 30-day period, over a 6-week period, over all RMSSD values). Inone embodiment, an HRV at the start of a sleeping period is obtained byaveraging all HRV values obtained in a time period (e.g., 30 minutes, 60minutes, 90 minutes) following sleep onset and an HRV at waking isobtained by averaging all HRV values obtained in a time period (e.g., 30minutes, 60 minutes, 90 minutes) prior to waking.

Manipulating Sleep

In a preferred embodiment, the stress reduction and sleep promotionsystem includes AI algorithms and/or machine learning to promoterecovery in sleep by combining deep sleep, HRV, and resting heart rate.In another embodiment, the stress reduction and sleep promotion systemalso incorporates REM sleep, sleep onset, movement, respiration rate,and/or body temperature (e.g., core body temperature) into the AIalgorithms and/or the machine learning. In yet another embodiment, thestress reduction and sleep promotion system incorporates at least onewaking period, a time of the at least one waking period, and/or aduration of the at least one waking period.

In one embodiment, core body temperature (CBT) is set as relative to anindividual CBT minimum (set at 0°). Each 30 second interval is assigneda circadian phase between 0° to 359.9°. Each 360° period is equivalentto a 24-hour day (i.e., circadian rhythm). In one embodiment, the datais processed using a nonlinear mixed model. Additional informationregarding the nonlinear mixed model is available in Boudreau, Philippeet al., “Circadian variation of heart rate variability across sleepstages” Sleep vol. 36, 12 1919-28. 1 Dec. 2013, doi:10.5665/sleep.3230,which is incorporated herein by reference in its entirety. A CBT minimumgenerally occurs around 5 am on average, but an early riser may hit theCBT minimum earlier.

After a user's normal circadian rhythm is defined as described above, anaverage minimum CBT, a baseline of HRV, and sleep stage data are used tocreate a baseline. In a preferred embodiment, real-time data from bodysensors (e.g., heart sensor, body temperature sensor, movement sensor)is used to modify a temperature of the mattress pad. However, somecurrent sensors and wearables do not give accurate real-timeinformation. Therefore, in one embodiment, data averages and/orbaselines are analyzed with a rolling 7 days of data. Advantageously,this allows programmed temperature changes to modify sleep withoutreal-time data from body sensors.

In one embodiment, the stress reduction and sleep promotion system isprogrammed for a deep sleep recovery focus. A deep sleep percentage hasa 65% weighting, an HRV has a 20% weighting, and a resting heart ratehas a 15% weighting. In another embodiment, a deep sleep percentage hasa 50% weighting, an HRV has a 25% weighting, and a resting heart ratehas a 25% weighting.

The stress reduction and sleep promotion system preferably incorporatesdata including, but not limited to, weight, age, gender, medications,sleep onset, desired wake time, sleep wake zone, sleep stage, pivotpoints for sleep cycles, athletic performance, heart rate, heart ratevariability, body temperature, and/or stress. This data is obtainedthrough the body sensors, the user input, the historical objective data,and/or the historical subjective data. The stress reduction and sleeppromotion system analyzes the data to determine a core body temperaturethroughout a sleeping period, resting heart rate, heart ratevariability, sleep cycles (including pivot points), deep sleeppercentage, deep sleep timing, a number of sleep cycles containing deepsleep, a time of a minimum core body temperature, a bedtime core bodytemperature, and/or a morning core body temperature. The data is used tocontrol core body temperature, sleep cycles, deep sleep percentage,pivot points, a number of wake times in a sleep period, a wake time,and/or sleep onset by varying the temperature of the mattress pad.Advantageously, this allows improvement in deep sleep, recovery, restingheart rate, metabolism, immune system function, stress levels, and/orathletic performance.

FIG. 38A illustrates a hypnogram of one sleep cycle prior to cooling.The hypnogram includes four major pivot points 602, 604, 606, and 608.The first pivot point 602 is the point where the stress reduction andsleep promotion system begins to decrease the temperature of themattress pad. The second pivot point 604 is the point where thetemperature of the mattress pad has reached peak cooling. The thirdpivot point 606 is the point of movement out of deep sleep. The fourthpivot point 608 is the end of the sleep cycle. In one example, if a userwakes at the fourth pivot point 608 consistently, the stress reductionand sleep promotion system further lowers the temperature of themattress pad by 0.56-1.1° C. (1-2° F.) at the third pivot point 606 toprevent waking at the end of the sleep cycle. In another example, thestress reduction and sleep promotion system raises the temperature ofthe mattress pad at the third pivot point 606 by 0.56-1.1° C. (1-2° F.)to encourage more REM sleep for a user who desires additional cognitiveand/or emotional recovery. The pivot points are obtained from bodysensors including, but not limited to, the body temperature sensor, themovement sensor, and/or the heart sensor.

FIG. 38B illustrates a hypnogram of one sleep cycle after cooling. Thefluctuations between N2 and N3 sleep seen in the hypnogram of FIG. 38Adiminish with cooling as seen in FIG. 38B.

FIG. 39 illustrates a hypnogram of a sleeping period. The hypnogramincludes a first sleep cycle, a second sleep cycle, a third sleep cycle,a fourth sleep cycle, and a fifth sleep cycle. The first sleep cyclepreferably has at least 30 minutes of deep sleep and more preferably hasabout 40 minutes of deep sleep. The second sleep cycle preferably has atleast 25 minutes of deep sleep. The third sleep cycle preferably has atleast 20 minutes of deep sleep. The fourth sleep cycle preferably has atleast 15 minutes of deep sleep. The fifth sleep cycle preferably has atleast 5 minutes of deep sleep. For sleeping periods of less than 6hours, it is likely that there are only four sleep cycles. The hypnogramincludes the four major pivot points 602, 604, 606, and 608 and aplurality of minor pivot points 650.

In a first example, the stress reduction and sleep promotion system isused to increase deep sleep for a 40 year old user. The user has astarting baseline as follows: a core body temperature (CBT) of 36.8° C.(98.2° F.) at 5:30 AM, a sleep onset time of 10:00 PM, a wake time of6:00 AM, a total deep sleep percentage of 11%, a total deep sleep amountof 56 minutes, an HRV average of 28, and a resting heart rate of 72 bpm.When the user attempts to go to sleep, the mattress pad is set atambient temperature (i.e., room temperature). At sleep onset, thetemperature of the mattress pad drops per a schedule to 15.6° C. (60°F.). In one example, the schedule is a decrease of 4.44° C. (8° F.) in30 minutes after the user is in light sleep is a pivot point in thesleep cycle. The user will no longer notice that the temperature of themattress pad is cooler than might be comfortable for the user. Thechange to the above set points is clear on a sleep tracker, but thefirst sleep cycle is longer (e.g., double) and is often “deeper” thanbefore temperature manipulated sleep. Additionally, a resting heart rateand a respiratory rate of the user drops. An HRV value also changes, butmay require 3-7 sleeping periods (e.g., nights) of temperaturemanipulated sleep before showing a change. Over a period of 3 months,the user has a new baseline as follows: a core body temperature (CBT) of36.6° C. (97.8° F.) at 4:05 AM, a sleep onset time of 10:00 PM, a waketime of 6:00 AM, a total deep sleep percentage of 19%, a total deepsleep amount of 1 hour 56 minutes, an HRV average of 54, and a restingheart rate of 66 bpm. Further, before blood work of the user indicatedHashimoto's disease with thyroid problems eventually leading to thyroidfailure. Blood work of the user following temperature modified sleepindicated a complete reversal of symptoms and signs of disease in 6months.

As previously described, in one embodiment, the mattress pad includes awarm awake feature. After the user reaches the minimum CBT, the bodyneeds to warm up. The mattress pad needs to be thermally neutral to warminstead of cool. In one example, a warm awake feature increases thetemperature of the mattress pad 4.44° C. (8° F.) in 30 minutes. Inanother example, a warm awake feature increases the temperature of themattress pad 4.44° C. (8° F.) in 15 minutes. Advantageously, using afaster rate of warming allows a user who gets less than 7 hours of sleep(e.g., 6 hours) to maximize the amount of sleep obtained in a sleepingperiod.

In another example, the stress reduction and sleep promotion system isused to treat depression or other similarly presenting mental disordersfrom a sleep cycle perspective. Extensive evidence suggests thatdepression is closely related to difficulty sleeping. Insomnia is adisorder of excessive wakefulness during the night. This hyperarousaloften masks sleepiness during the day. Depressed individuals often havea higher core body temperature than non-depressed individuals and ablunted core body temperature rhythm. Some depressed individuals havehyperthermia (e.g., a core body temperature of 0.83-1.1° C. (1.5-2° F.)greater than normal). Hyperthermia is linked to chronic inflammation,fatigue, and stress. Insomnia in combination with depression is alsomarked by disrupted REM sleep. REM sleep is hypothesized to controlemotional regulation. Less REM sleep leads to less emotional processing,which contributes to depression.

In the example of treating depression, the user has a starting baselineas follows: a sleep onset time of 10:00 PM, a wake time of 6:00 AM, atotal deep sleep percentage of 3%, a total deep sleep amount of 16minutes, an HRV average of 22, and a resting heart rate of 74 bpm. Theuser reported regular night terrors, restless dreams, and frequentwake-ups. Over a period of 6 months, the user has a new baseline asfollows: a sleep onset time of 10:00 PM, a wake time of 6:00 AM, a totaldeep sleep percentage of 12%, a total deep sleep amount of 1 hour 7minutes, an HRV average of 78, and a resting heart rate of 63 bpm.Further, the user reported that the night terrors almost completelystopped and very few wake-ups at night.

In yet another example, the stress reduction and sleep promotion systemis used to treat difficulty sleeping related to cancer treatment.Between a third and a half of all cancer patients have difficultysleeping through the night according to the National Institutes ofHealth. Insomnia can negatively impact both the health and stamina ofthe patient both during and after cancer treatment. During the treatmentprocess, CBT highs and lows of the circadian rhythm are disrupted. Oftencold and warm therapy is needed to sleep and maintain the circadianrhythm. Immune system fluctuations due to the cancer treatment makes itdifficult to maintain a consistent CBT.

In still another example, the stress reduction and sleep promotionsystem is used to assist athletes (e.g., professional athletes) withrecovery. Athletes have a better trained thermoregulation system incomparison to non-athletes. For example, athletes have a faster sweatproduction and produce a larger amount of sweat. During physicalactivity, athletes may have a CBT of up to 40° C. (104° F.). Thesedifferences in the thermoregulation system often cause athletes tosuffer from hyperthermia at night, which leads to poor quality sleep.Athletes may also be more sensitive to environmental and physicalconditions than non-athletes including, but not limited to, bedtemperature, changes in bedding and/or mattresses, ambient temperature,poor room circulation, dehydration, and/or stress from activitiesearlier in the day. As a result, athletes may have difficulty obtainingdeep sleep later in the sleeping period (e.g., after the 4^(th) hour ofsleep). For an athlete, HRV is naturally high as long as the athlete canstay asleep. The mattress pad aids in managing the user's naturalmetabolism that causes the user's body to heat up quickly and startsweating during deep sleep. By dropping the temperature of the mattresspad, the user is able to obtain more deep sleep.

In one example, a user has a starting amount of deep sleep of less thanone hour, a starting HRV equal to 80% of average relative to the user'sage, and a starting resting heart rate with a lowest value beforewaking. The stress reduction and sleep promotion system is programmedwith the goals of increasing the amount of deep sleep to 2 hours oftotal sleep time, improving the HRV to be within an average range forthe user's age, and moving the resting heart rate lowest value to themiddle of the night to create a hammock-shaped curve. To accomplishthese goals, the stress reduction and sleep promotion system decreasesthe temperature of the mattress pad by 1.1-5.6° C. (2-10° F.). Theamount of cooling depends on the starting deep sleep value, the startingHRV, the starting resting heart rate, body mass, and/or thermogenesishistory.

The hypothalamus is responsible for maintaining homeostasis, whichincludes maintaining core body temperature. Temperature influences sleepstages and circadian rhythms through the autonomic nervous system (ANS).HRV is one way to measure how the autonomic nervous system isfunctioning and the balance between the sympathetic nervous system (SNS)and the parasympathetic nervous system (PNS). At the start of the sleepperiod, the SNS is dominant. As core body temperature drops, the PNS,which is responsible for recovery and digestion, becomes dominant. Whenthe PNS is dominant, heart rate is reduced. Finally, the SNS becomesdominant again as the individual wakes, resulting in an increased heartrate. This is what produces the hammock-shaped curve in PRIOR ART FIG.36. If the core body temperature does not drop enough for the PNS tobecome dominant until closer to wakening, the curve is not a hammockshape.

In one embodiment, sensors provide feedback to the stress reduction andsleep promotion system regarding sleep environment versus core bodytemperature to determine a number of watts of heat generated during anaverage sleep session. An average adult generates 60-100 W of heat peraverage sleep session.

An individual generates power that is measured in watts. Power iscalculated by measuring energy per time. An average human generatesapproximately 100 W in a typical day. The power generated by theindividual depends on several factors including, but not limited to, anactivity level, a weight, and/or a metabolic rate. Further, an amount ofpower obtained from a diet is calculated by converting kilocalories intowatts. For example, 2500 kcal is equivalent to a power of 121.5 W.

In another embodiment, body temperature is used to track a menstrualcycle of a user. Examples of tracking a menstrual cycle using bodytemperature are found in U.S. Pat. Nos. 8,834,389 and 9,861,344, each ofwhich is incorporated herein by reference in its entirety.

In yet another embodiment, body temperature is used to determine how auser is responding to a training and/or an exercise program. A decreasedbody temperature during the training and/or the exercise programindicates that the user needs to decrease an intensity level of thetraining and/or the exercise program. Recent studies indicate that womenshould restrict high intensity training during the second half of theirmenstrual cycle. For further discussion of the effects of menstrualcycle on training, see Julian, Ross et al. “The effects of menstrualcycle phase on physical performance in female soccer players” PloS onevol. 12, 3 e0173951. 13 Mar. 2017, doi:10.1371/journal.pone.0173951,which is incorporated herein by reference in its entirety.

In another embodiment, the stress reduction and sleep promotion systemis used to reset a circadian rhythm. In one embodiment, the circadianrhythm reset aids in managing shift work, seasonal circadian disorder,and/or jet lag. To reset a circadian rhythm, a lowest CBT is determined.If an average sleeping period is less or equal to seven hours, thelowest CBT is generally around 2 hours before waking. If an averagesleeping period is greater than seven hours, the lowest CBT is generallyaround 3 hours before waking. For a user traveling east, the circadianrhythm is advanced. To advance the circadian rhythm, a user cools thebody (e.g., using a mattress pad) and/or avoids light for three hoursbefore the lowest CBT and warms the body (e.g., using a mattress pad)and/or is exposed to light for three hours after the lowest CBT. For auser traveling west, the circadian rhythm is delayed. To delay thecircadian rhythm, a user warms the body (e.g., using a mattress pad)and/or is exposed to light for three hours before the lowest CBT andcools the body (e.g., using a mattress pad) and/or avoids light forthree hours after the lowest CBT. In one embodiment, a change of up to 1hour in either direction (i.e., delay or advance) is used to shift thelowest CBT. In another embodiment, a change of up to 2 hours in eitherdirection (i.e., delay or advance) is used to shift the lowest CBT.

FIG. 40 is a schematic diagram of an embodiment of the inventionillustrating a computer system, generally described as 800, having anetwork 810, a plurality of computing devices 820, 830, 840, a server850, and a database 870.

The server 850 is constructed, configured, and coupled to enablecommunication over a network 810 with a plurality of computing devices820, 830, 840. The server 850 includes a processing unit 851 with anoperating system 852. The operating system 852 enables the server 850 tocommunicate through network 810 with the remote, distributed userdevices. Database 870 may house an operating system 872, memory 874, andprograms 876.

In one embodiment of the invention, the system 800 includes acloud-based network 810 for distributed communication via a wirelesscommunication antenna 812 and processing by at least one mobilecommunication computing device 830. In another embodiment of theinvention, the system 800 is a virtualized computing system capable ofexecuting any or all aspects of software and/or application componentspresented herein on the computing devices 820, 830, 840. In certainaspects, the computer system 800 may be implemented using hardware or acombination of software and hardware, either in a dedicated computingdevice, or integrated into another entity, or distributed acrossmultiple entities or computing devices.

By way of example, and not limitation, the computing devices 820, 830,840 are intended to represent various forms of digital computers 820,840, 850 and mobile devices 830, such as a server, blade server,mainframe, mobile phone, personal digital assistant (PDA), smartphone,desktop computer, netbook computer, tablet computer, workstation,laptop, and other similar computing devices. The components shown here,their connections and relationships, and their functions, are meant tobe exemplary only, and are not meant to limit implementations of theinvention described and/or claimed in this document

In one embodiment, the computing device 820 includes components such asa processor 860, a system memory 862 having a random access memory (RAM)864 and a read-only memory (ROM) 866, and a system bus 868 that couplesthe memory 862 to the processor 860. In another embodiment, thecomputing device 830 may additionally include components such as astorage device 890 for storing the operating system 892 and one or moreapplication programs 894, a network interface unit 896, and/or aninput/output controller 898. Each of the components may be coupled toeach other through at least one bus 868. The input/output controller 898may receive and process input from, or provide output to, a number ofother devices 899, including, but not limited to, alphanumeric inputdevices, mice, electronic styluses, display units, touch screens, signalgeneration devices (e.g., speakers), or printers.

By way of example, and not limitation, the processor 860 may be ageneral-purpose microprocessor (e.g., a central processing unit (CPU)),a graphics processing unit (GPU), a microcontroller, a Digital SignalProcessor (DSP), an Application Specific Integrated Circuit (ASIC), aField Programmable Gate Array (FPGA), a Programmable Logic Device (PLD),a controller, a state machine, gated or transistor logic, discretehardware components, or any other suitable entity or combinationsthereof that can perform calculations, process instructions forexecution, and/or other manipulations of information.

In another implementation, shown as 840 in FIG. 40, multiple processors860 and/or multiple buses 868 may be used, as appropriate, along withmultiple memories 862 of multiple types (e.g., a combination of a DSPand a microprocessor, a plurality of microprocessors, one or moremicroprocessors in conjunction with a DSP core).

Also, multiple computing devices may be connected, with each deviceproviding portions of the necessary operations (e.g., a server bank, agroup of blade servers, or a multi-processor system). Alternatively,some steps or methods may be performed by circuitry that is specific toa given function.

According to various embodiments, the computer system 800 may operate ina networked environment using logical connections to local and/or remotecomputing devices 820, 830, 840, 850 through a network 810. A computingdevice 830 may connect to a network 810 through a network interface unit896 connected to a bus 868. Computing devices may communicatecommunication media through wired networks, direct-wired connections orwirelessly, such as acoustic, RF, or infrared, through an antenna 897 incommunication with the network antenna 812 and the network interfaceunit 896, which may include digital signal processing circuitry whennecessary. The network interface unit 896 may provide for communicationsunder various modes or protocols.

In one or more exemplary aspects, the instructions may be implemented inhardware, software, firmware, or any combinations thereof. A computerreadable medium may provide volatile or non-volatile storage for one ormore sets of instructions, such as operating systems, data structures,program modules, applications, or other data embodying any one or moreof the methodologies or functions described herein. The computerreadable medium may include the memory 862, the processor 860, and/orthe storage media 890 and may be a single medium or multiple media(e.g., a centralized or distributed computer system) that store the oneor more sets of instructions 900. Non-transitory computer readable mediaincludes all computer readable media, with the sole exception being atransitory, propagating signal per se. The instructions 900 may furtherbe transmitted or received over the network 810 via the networkinterface unit 896 as communication media, which may include a modulateddata signal such as a carrier wave or other transport mechanism andincludes any delivery media. The term “modulated data signal” means asignal that has one or more of its characteristics changed or set in amanner as to encode information in the signal.

Storage devices 890 and memory 862 include, but are not limited to,volatile and non-volatile media such as cache, RAM, ROM, EPROM, EEPROM,FLASH memory, or other solid state memory technology; discs (e.g.,digital versatile discs (DVD), HD-DVD, BLU-RAY, compact disc (CD), orCD-ROM) or other optical storage; magnetic cassettes, magnetic tape,magnetic disk storage, floppy disks, or other magnetic storage devices;or any other medium that can be used to store the computer readableinstructions and which can be accessed by the computer system 800.

It is also contemplated that the computer system 800 may not include allof the components shown in FIG. 40, may include other components thatare not explicitly shown in FIG. 40, or may utilize an architecturecompletely different than that shown in FIG. 40. The variousillustrative logical blocks, modules, elements, circuits, and algorithmsdescribed in connection with the embodiments disclosed herein may beimplemented as electronic hardware, computer software, or combinationsof both. To clearly illustrate this interchangeability of hardware andsoftware, various illustrative components, blocks, modules, circuits,and steps have been described above generally in terms of theirfunctionality. Whether such functionality is implemented as hardware orsoftware depends upon the particular application and design constraintsimposed on the overall system. Skilled artisans may implement thedescribed functionality in varying ways for each particular application(e.g., arranged in a different order or partitioned in a different way),but such implementation decisions should not be interpreted as causing adeparture from the scope of the present invention.

The above-mentioned examples are provided to serve the purpose ofclarifying the aspects of the invention, and it will be apparent to oneskilled in the art that they do not serve to limit the scope of theinvention. By way of example, the temperature regulating article can bea mattress pad, a sleeping bag, a cushion, or a blanket. Theabove-mentioned examples are just some of the many configurations thatthe mentioned components can take on. All modifications and improvementshave been deleted herein for the sake of conciseness and readability butare properly within the scope of the present invention.

The invention claimed is:
 1. A system for cooling a fluid, comprising: acontrol unit comprising: at least one thermoelectric module connected toa fluid reservoir, containing the fluid; at least one heat pipeconnecting the at least one thermoelectric module with a plurality ofheat sinks; at least one fan attached to each of the plurality of heatsinks; and an electromagnetic field (EMF) shield, wherein the EMF shieldis operable to reduce the strength of the EMF produced by the controlunit outside of the control unit; wherein the plurality of heat sinksare aligned along a central axis.
 2. The article of claim 1, wherein theat least one thermoelectric module is not aligned along the centralaxis.
 3. The system of claim 1, wherein the at least one thermoelectricmodule includes four Peltier chips.
 4. The system of claim 1, whereineach of the at least one fan attached to each of the plurality of heatsinks is operable to blow air to or suck air from the plurality of heatsinks in a single direction.
 5. The system of claim 1, furthercomprising a bedding device including fluid channels, wherein thecontrol unit is operable to pump the fluid from the fluid reservoir intothe fluid channels of the bedding device.
 6. The system of claim 5,wherein the bedding device includes a flexible mattress pad.
 7. Thesystem of claim 1, wherein the fluid is water.
 8. The system of claim 1,wherein the EMF shield includes a chassis connecting the plurality ofheat sinks.
 9. The system of claim 1, wherein the plurality of heatsinks each include a plurality of spaced-apart planar fins extendingperpendicularly outward from a base.
 10. The system of claim 1, whereinthe fluid reservoir includes a fill opening, a fluid outlet, and a fluidreturn.
 11. A system for cooling a fluid, comprising: a control unitcomprising: at least one thermoelectric module connected to a fluidreservoir, containing the fluid; at least one heat pipe connecting theat least one thermoelectric module with a plurality of heat sinks; atleast one fan attached to each of the plurality of heat sinks; whereinthe plurality of heat sinks are aligned along a central axis; and abedding device having fluid channels therein, wherein the control unitis operable to pump the fluid from the fluid reservoir into the beddingdevice.
 12. The system of claim 11, wherein the control unit furtherincludes an electromagnetic field (EMF) shield, wherein the EMF shieldis operable to reduce the strength of the EMF produced by the controlunit outside of the control unit.
 13. The system of claim 12, whereinthe EMF shield includes a chassis connecting the plurality of heatsinks.
 14. The system of claim 11, wherein the at least onethermoelectric module is not aligned along the central axis.
 15. Thesystem of claim 11, wherein the at least one thermoelectric moduleincludes four Peltier chips.
 16. The system of claim 11, wherein each ofthe at least one fan attached to each of the plurality of heat sinks areoperable to blow air to or suck air from the plurality of heat sinks ina single direction.
 17. The system of claim 11, wherein the fluid iswater.
 18. A system for cooling a fluid, comprising: a control unitcomprising: at least one thermoelectric module connected to a fluidreservoir, containing the fluid; a plurality of heat sinks connected tothe at least one thermoelectric module; at least one fan attached toeach of the plurality of heat sinks; and an electromagnetic field (EMF)shield, wherein the EMF shield is operable to reduce the strength of theEMF produced by the control unit outside of the control unit; whereinthe plurality of heat sinks are aligned along a central axis; andwherein each of the at least one fan attached to each of the pluralityof heat sinks are operable to blow air to or suck air from the pluralityof heat sinks in a single direction.
 19. The system of claim 18, whereinthe at least one thermoelectric module is not aligned along the centralaxis.
 20. The system of claim 18, wherein the EMF shield includes achassis connecting the plurality of heat sinks.